2

i

DECLARATION

OF JEROME P. SKELLY, PH.D.

I, JEROME P. SKELLY, Ph.D., have been retained as an expert on behalf of King Pharmaceuticals, Inc. (“King”). I have been asked to assessthe pharmacokinetic results of

certain clinical studies’ conducted in connection with the muscle relaxant drug product, SkelaxinB (metaxalone). In particular, I have been asked to opine on the importance of including such results in the labeling for generic versions of SkelaxinB. I have also been asked provide comments on the submissions made to the United States Food and Drug Administration (“FDA”) on behalf of CorePharma LLC (“Core”), including the Declaration of Paul Bass (“Bass Declaration”), and Mutual Pharmaceutical Co., Inc. (“Mutual”). I. 1. STATEMENT OF QUALIFICATIONS

I received my undergraduate degree and my Ph.D. in Chemistry from Wayne State

University in Detroit, and completed a post-doctorate in Pharmaceutics at UCSF in San Francisco. 2. For more than 24 years, I held senior scientific and management positions in FDA.

During much of that time period, I was Director and Program Manager for Biopharmaceutics. I was also a World Health Organization consultant to Egypt. At the time of my retirement, I was a member of the Federal Government’ ‘ s Senior Executive Service’ holding joint appointments as Deputy Director of CDER’ Office of Research and Associate Director (for Science) in OGD. s

1

Although King recently acquired the Skelaxin@ NDA and did not sponsor the clinical studies discussed in

this declaration, for ease of reference, I will refer to them as King’ studies. s

3.

I am President-Elect of the American Association of Pharmaceutical Scientists;

Immediate Past Chairman of the Board of Directors of the Product Quality Research Institute [(PQRI), a consortium of AAPS, FDA, USP, Industry and other health interest groups and societies]; and Adjunct Professor of Biopharmaceutics at the College of Pharmacy, University of Cincinnati. I am also a Charter Member of FDA’ Alumni Association. I am also a s biopharmaceutical consultant, and I presently sit on the scientific and/or strategic advisory boards of several pharmaceutical firms. 4. I have made more than 250 scientific and policy presentations, and authored/co-authored

more than 100 publications, in addition to editorials and a significant number of posters, monographs, abstracts, and guidelines. I am co-editor of books in the area of pharmacokinetics, pharmacodynamics, and toxicokinetics, and a member of the Editorial Boards of the Marcel Dekker Pharmaceutic Series, the Journal of Clinical Research and Regulatory Affairs, and the International Editorial Advisory Board of the 2’ Edition of the Encyclopedia of nd Pharmaceutical Technology. I have also served on the Editorial Board of the Journal of Clinical Pharmacology. 5. I was twice given the Public Health Services “Equal Opportunity Award”, several

commendations in recognition for service to the public health, a “Commissioner’ Special s Citation” for work on the electronic submission of data (CANDA), and the FDA’ highest award s “The FDA Award of Merit” for my work in generic drug compliance and biopharmaceutics. I am the recipient of the 1996 AAiPS “Recognition Award” for playing a leading role in the globalization of quality standards and devoted service to the advancement of the pharmaceutical sciences; and the 2002 AAPS’ “Distinguished Service Award” for contributions to AAPS.

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6.

I am a Fellow and Sustaining Member of AAPS, a Fellow of both the American College

of Clinical Pharmacology and the American Association of Indian Pharmaceutical Scientists, and a member of both Phi Lambda Upsilon (Chemistry Honors Society) and the Research Society of America. I am a past Vice-Chair, Chair-Elect and Chair of the AAPS’ Pharmacokinetics, Pharmacodynamics, & Drug Metabolism Section (PPDM) and was actively involved with the development and organization of PPDM’ first ‘ s Open Forum’ I have chaired the PPDM and . Regulatory Science (RS) Section’ Strategic Planning and Fellows Nomination’ Committees, s and represented PPDM on the Annual Meeting Committee. Additionally, I was the 1990-93 Elected Member at Large on AAPS’ Executive Council and served on the RS Section’ s Executive Committee for eight years. I have also been a member of the AAPS’ Governance and Fellows Task Forces, and served nine terms (once as ‘ Outside Reviewer’ and three times as Chair) on the AAPS’ Fellows Selection Committee. 7. I have been actively involved with many significant scientific activities including

organizing, chairing, moderating, and speaking at numerous scientific symposia, short-courses, and workshops. As an FDA Senior Executive, I initiated the holding of public FDA workshops as a way of tackling and addressing complex scientific/regulatory problems in an open forum, and publishing the results -- among the more significant of these were the AAPS-FDA ‘ Scale-Up Workshops’ which set the stage for SUPAC. , II. 8. OVERVIEW OF OPINION

Based on my review of a March 1,2004 letter from the FDA Office of Generic Drugs to applicants for generic versions of metaxalone, it

Abbreviated New Drug Application (“ANDA”)

is my understanding that the FDA may be planning to permit the omission of the results of human studies demonstrating the increase in the bioavailability of metaxalone when co-3-

administered with food from the labeling for generic versions of SkelaxinB, in spite of the fact that this information properly appears in the labeling of SkelaxinB. It is also my understanding that a SkelaxinB labeling supplement proposing to including the results of additional clinical studies demonstrating the effect of age and gender on the bioavailability of metaxalone in both the fed state and the fasted state is currently pending before the FDA. 9. I am aware that King submitted a Citizen Petition to the FDA explaining why the

omission of the results of the clinical studies from the labeling for generic metaxalone products would render those generic products less safe or effective than Skelaxinm for their remaining conditions of use. It is my understanding that Core and Mutual each submitted comments to the FDA supporting their efforts to carve out the pharmacokinetic data from the labeling for generic versions of Skelaxin@, but neither have submitted scientific data in support of their positions. 10. Based on my review of the data and underlying studies that are described in the current

SkelaxinB labeling and in the pending Skelaxin@ labeling supplement, I have been asked to assessthe study results concerning the effects of food, age, and gender on the bioavailability of SkelaxinB. In addition, I have been asked to comment on whether the studies were adequately and appropriately designed and conducted. I have also been asked to assesswhether the omission of the results of these clinical studies from the labeling for generic metaxalone products can pose safety and efficacy issues. 11. The data from King’ clinical studies demonstrate that bioavailability of SkelaxinB varies s

as follows: an increase in bioavailability under fed conditions as compared to fasted conditions; an age-related increase in bioavailability in the fasted state only; and an increase in bioavailability when administered to females as compared to males. These results, in particular -4-

the increase in bioavailability under fed conditions, indicate that safety and efficacy issues of clinical significance may exist. In the absence of any contrary clinical data, any presumption that the pharmacokinetic information can be omitted from the labeling for generic metaxalone products without affecting the safety and efficacy of those products is based in conjecture rather than scientific fact. It is my opinion that information describing the effects of food, age, and gender on the bioavailability of metaxalone is properly included in labeling -- both brand and generic -- and that omission of such information would pose safety and efficacy concerns. 12. I have also been asked to comment on the submissions made by Core and Mutual. In

particular, I will explain why any variability in the individual pharmacokinetic data due to gastric phenomena does not negate the existence of a food effect. I will also explain the defects in any argument that the pharmacokinetic data lack clinical relevance because the studies only measured metaxalone blood levels and measured no clinical end points. I will also address criticisms regarding the utilization of single dose studies to demonstrate food effects; the utilization of a standardized high fat meal to demonstrate food effects; the utilization of a metaanalysis to determine age and gender effects; and the subject size of the clinical studies. 13. In my opinion, there is no evidence to support the conclusions drawn by Core and its

expert or by Mutual that the bioavailability studies have no clinical relevance. I am not aware of any clinical data that contradict the pharmacokinetic data generated from the bioavailability clinical studies designed to demonstrate the effects of food, age, and gender on the bioavailability of SkelaxinB, or any clinical data that would cast doubt on their reliability. Not only are Core and Mutual’ arguments unsupported by any clinical data, but they are also simply s irrelevant to the question of whether the omission of results of bioavailability studies from the labeling for generic metaxalone products raises safety and efficacy concerns. -5-

III.

THE BIOAVAILABILITY OF SKELAXIN INCREASES SIGNIFICANTLY THE FED STATE AS COMPARED TO THE FASTED STATE A.

IN

Clinical Studies Designed to Examine the Effect of Food on the Bioavailability of Skelaxin Demonstrate The Existence of a Significant Food Effect

14.

I have reviewed Clinical Study AN 15 1607- 10 1 (“Study 10 1”) entitled “Bioavailability

Study of SkelaxinB (Metaxalone) 400mg Administered With and Without Food to Healthy Volunteers,” which was designed as a single-dose, two period, randomized, crossover trial completed with 42 healthy volunteers. 15. Study subjects received two different treatments. For treatment A the volunteers were

administered 1 x 400mg of SkelaxinQ with food; for treatment B the volunteers were administered 1 x 400mg of SkelaxinB without food. 16. The primary objective of Study 101 was to evaluate the effect of food on the

bioavailability of a 400mg tablet of Skelaxin@ in healthy volunteers. 17. The results reported for Study 10 1 demonstrate that the bioavailability of a SkelaxinB

400mg tablet was increased when administered with food. 18. I have also reviewed Clinical Study AN15 1607-103 (“Study 103”) entitled

“Bioequivalence and Safety Study of Skelaxin@ (Metaxalone) 1 x 800mg Tablet and 2 x 400mg Tablets Under Fasted and Fed Conditions in Healthy Volunteers,” which was designed as a single-dose, four period, randomized, crossover trial completed with 59 healthy volunteers. 19. The volunteers of Study 103 received four different treatments. Treatment A involved

administration of 1 x 8OOmgof SkelaxinB without food; Treatment B, administration of 2 x

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400mg of SkelaxinB without food; Treatment C, administration of 1 x 800mg of SkelaxinB with food; and Treatment D, administration of 2 x 400mg of SkelaxinO with food. 20. Study 103 involved two objectives: (1) the determination of whether a 8OOmgtablet was

bioequivalent to the 400mg tablet; and (2) the determination of whether food affected the bioavailability of SkelaxinB. 21. With respect to the first objective, Study 103 established that the administration of 1 x

800 mg SkelaxinB (metaxalone) tablet was bioequivalent to the administration of 2 x 400 mg SkelaxinB tablets. 22. With respect to the second objective, Study 103 established that the administration of

Skelaxin@ 1 x 800 mg tablet with food increased the rate and extent of absorption when compared to the administration of Skelaxin@ 1 x 800mg without food. 23. Also with respect to the second objective, Study 103 established that the administration

of SkelaxinB 2 x 400 mg tablets with food increased the rate and extent of absorption when compared to the administration of SkelaxinB 2 x 400mg tablets without food. 24. Study 101 was the initial study conducted to determine the effect of food on the

bioavailability of SkelaxinB. As noted above, the results of Study 101 revealed that the administration of Skelaxin@ with food dramatically increases its bioavailability as compared to its administration without food. The results of Study 10 1 were confirmed by the results of Study 103 and, based on the results of these two clinical studies, it is clear that the administration of SkelaxinB with food results in a significant increase in oral bioavailability.

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B. 25.

Variability In the Individual of a Significant Food Effect

Pharmacokinetic

Data Does Not Negate the Existence

The submissions on behalf of Core and Mutual present no clinical data that refute the

existence of the observed food effect. Core and its expert note that, in a few study subjects, fasted-state administration of metaxalone produced plasma concentration levels that exceeded those in the fed state. They speculate that this occurred due to fasted-state administration at a time that coincides with enhanced digestive functions that occur during Phase III of the migrating motor complex, or MMC. Even if true, this theory does not support Core’ position. s 26. The results of King’ studies clearly establish the existence of a significant food-effect. s

Notably, the study analyses include the individual subject data discussed by Core’ expert. In s the absence of clinical data refuting the results of the studies, the statements made by Core and its expert have no basis. Moreover, the bioavailability of all drugs, including drugs that have food effects such as metaxalone, would be affected by this allegedly normal enhanced digestive process. Accordingly, its occurrence in the King studies provides no basis to reject or even question King’ food effect data. The purported existence of a digestive function that could s increase oral bioavailability of metaxalone in the fasted state does not and cannot negate the existence of a significant, clinically established food effect. Finally, assuming arguendo that this gastric phenomena exists, knowledge that Phase III of the MMC occurs when fasting and that administration of metaxalone (or any other drug) during this phase may enhance bioavailability cannot be used by practitioners to determine proper dosage and administration because it is impossible to predict exactly when the enhanced digestive process will occur, so there is no way for patients or their physicians to ensure that drug products are taken at a time that coincides with Phase III of the MMC.

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V.

THE BIOAVAILABILITY GENDER A.

OF SKELAXIN

IS AFFECTED

BY AGE AND

Clinical Studies Designed to Examine the Effect of Age and Gender on the Bioavailability of Skelaxin and the Meta-Analysis

27.

I have reviewed Clinical Study ELN 151607-105 (“Study 105”) entitled “A Study to

Evaluate the Pharmacokinetics of SkelaxinO (Metaxalone) 2 x 400mg Tablet Administered to Young and Elderly Volunteers Under Fed and Fasted Conditions,” which was designed as a single-dose, randomized, two-period crossover trial and completed with 44 volunteers. 28. I have also reviewed Clinical Study AN1 5 1607-l 06 (“Study 106”) entitled “A Study to

Evaluate the Effect of Gender on the Pharmacokinetics of Skelaxin@ (Metaxalone) 2 x 400mg Administered to Healthy Volunteers” which was designed as a single-dose, parallel design trial and completed with 48 volunteers. The study was designed to determine the effect of gender on the pharmacokinetics of 2 x 400mg tablets of SkelaxinB administered under fasted conditions to 24 male and 24 female volunteers. 29. I have also reviewed the meta-analysis of Study 105 and Study 106 conducted in

combination with Study 101 and Study 103 to investigate the effect of age and gender on the bioavailability of Skelaxin@ in both the fed and fasted states. The results of Study 105, Study 106, and the meta-analysis revealed that, in the fed state, age has little or no effect upon the bioavailability of SkelaxinB -- regardless of gender. In contrast, in the fasted state, bioavailability was statistically increased with an increase in age -- also regardless of gender. Moreover, in both the fed and fasted states, bioavailability of SkelaxinB is higher in females than in males. B. The Age-Effect Data Is Statistically Significant -9-

30.

Based on the results of the clinical studies and the meta-analysis, it is clear that

administration of SkelaxinB with food can cause a statistically significant increase in its oral bioavailability. In addition, Study 105, Study 106, and the meta-analysis reveal that in the fasted

state, bioavailability was statistically increased with an increase in age. Moreover, it is clear that the age-related variations in the bioavailability of metaxalone are minimized when SkelaxinB is administered in the presence of food. 31. The data indicate that age is much more strongly associated with bioavailability in the

fasted condition than in the fed condition, and Core and its expert fail to refute this fact. Based on the studies and the meta-analysis, it is clear that the estimated effect of age on AUC under fasted conditions is approximately three to four times larger than the estimated effect under fed conditions. The difference between the estimated effect of age on C,, under fasted vs. fed conditions is even larger. VI. 32. THE LACK OF EVIDENCE REGARDING CLINICAL RELEVANCE NOT CONSTITUTE EVIDENCE OF CLINICAL IRRELEVANCE DOES

It is my understanding that Study 101 and Study 103 were submitted to the FDA and that

those studies are currently described in the Clinical Pharmacology section of the labeling for Skelaxin@. I have reviewed the current labeling for SkelaxinB. Specifically, the labeling describes the results of Study 101 and Study 103 that administration of Skelaxin@ with food results in a significant increase in oral bioavailability of metaxalone. 33. I have also reviewed the pending supplement proposing revised labeling for SkelaxinB

incorporating the data gathered from Study 105, Study 106, and the meta-analysis. The proposed labeling includes the pharmacokinetic data that demonstrate the effects of age and gender on oral bioavailability and the effect of food upon the variations in bioavailability caused by differences -lO-

in age. Based on these statistically significant data, the proposed labeling also includes a recommendation that SkelaxinB be administered with food to ensure more predictable plasma levels of metaxalone. A. Scientific Data Cannot Be Omitted from Labeling In the Absence of Clinical Evidence Demonstrating that Such Omission Does Not Have an Impact on Safety or Efficacy

34.

The results of King’ bioavailability studies should not be omitted from the labeling for s

generic metaxalone products. Based on my experience at and with FDA, this is the first time I have seen the Agency consider deletion of this type of scientific data from a generic label. I believe that the pharmacokinetic data is important for physicians who must make decisions concerning the optimal dosage and administration of SkelaxinB and all other drug products, whether innovator or generic. Because the results of bioavailability studies provide information that can be relevant under specific conditions and to specific patients in determining the optimal dosage regimen, it is critical that this information be provided in both brand and generic labels. I believe that it is of the utmost importance that such scientific data not be deleted from the label of any drug. 35. Core and Mutual fail to identify any clinical evidence indicating that the bioavailability

data are clinically irrelevant and, instead, base their arguments on supposition. Each argues that because it is unknown whether or not there is a correlation between changes in plasma concentration levels and safety or efficacy, the pharmacokinetic data are clinically irrelevant. However, Core and Mutual err in presuming that the lack of evidence showing a correlation between plasma levels and safety or efficacy means that this information is not important. Changes in bioavailability are not immaterial to safety and efficacy. Any omission of pharmacokinetic data from a product’ labeling could raise serious concerns regarding safety and s - ll-

efficacy, and should not be undertaken without considerable scientific discussion and debate. To do so would open a Pandora’ box where all kinds of data can be deleted, subject only to a s particular reviewer’ personal bias. s 36. It is undisputed that, despite having a long history of use, information concerning

metaxalone remains incomplete. For instance, SkelaxinB’ mode of action and drug-drug s interactions currently remain unknown. In fact, until recently, no one had studied the pharmacokinetics of SkelaxinB. However, recent studies have demonstrated that metaxalone pharmacokinetics are affected by food. For FDA to require fed/fasting studies and not to include the information in the labeling -- on the basis that it is irrelevant -- would be a violation of the Helsinki Resolutions, whereby unnecessary clinical research in humans is precluded. B. 37. It Is Irrelevant That the Clinical Studies Did Not Measure Clinical Endpoints, and Instead Measured only Blood Plasma Levels of Metaxalone

Core and Mutual also err in assuming that because the King studies were not designed to

measure clinical endpoints, the pharmacokinetic data are clinically irrelevant. Studies investigating, directly, the clinical effect of a food effect are rare. Instead, bioavailability studies and bioequivalence studies, such as Studies 101 and 103, that do not measure clinical endpoints, are routinely conducted and data generated from such studies are included in product labeling. Core and Mutual do not dispute that the FDA requires submission of in vivo bioequivalence studies in both the fed and fasted states because of the existence of a food effect. FDA requires these studies to eliminate the concerns that stem from the potential for different safety and/or efficacy profiles. As such, the safety and efficacy of generic versions of Skelaxin@ can only be demonstrated by bioequivalence studies which themselves do not measure clinical endpoints. In fact, if FDA were to agree to omit the pharmacokinetic data from labeling for generic - 12-

metaxalone products, the Agency would be essentially reversing its determination that generics must show bioequivalence under both fed and fasted conditions. Based on my experience at and with FDA, it is my opinion that if the information is omitted and fed bioequivalence studies were still to be required, such clinical studies would be technically unnecessary and therefore possibly unethical. 38. Accordingly, although no clinical endpoints were measured, based on the results of

clinical studies, including Studies 101 and 103, FDA has acknowledged the import of the food effect data. In my opinion, the omission of the pharmacokinetic data demonstrating the existence of food, age, and gender effects from the labeling for generic products that require in vivo bioequivalence testing, such as metaxalone, is scientifically inappropriate. 39. The fact that King’ studies were not designed to measure clinical endpoints does not s

negate the results of those studies demonstrating that food, age and gender each have a significant effect on the bioavailability of metaxalone. In addition, the failure to measure clinical endpoints is not evidence that there is no correlation between plasma levels of metaxalone and safety or efficacy. Thus, the fact that the clinical studies did not measure clinical endpoints is simply irrelevant to the question of whether the pharmacokinetic data can be omitted from the labeling without raising issues of safety and efficacy. 40. Likewise, it cannot be presumed that because the King’ studies only measured blood s

plasma levels of metaxalone, that the resulting pharmacokinetic data are clinically irrelevant. At the very least, blood levels have clinical relevance to the extent that a drug such as metaxalone must reach the blood in order to have clinical effect. Changes in blood level can be an indication that there will be changes in pharmacologic effect. In fact, the bioavailability of an orally - 13 -

administered drug product with a systemic clinical effect is critical to such effect. Certainly, I am not aware of any scientific data that support an assertion that blood levels of metaxalone do not assure a clinical effect. Thus, in the absence of clinical evidence that there is no nexus between the blood levels of Skelaxin@ and its clinical safety or efficacy, there is no scientific basis for assuming that the pharmacokinetic data are immaterial to determining safe and effective use of Skelaxin@. VII. THE CLINICAL 41. STUDIES WERE PROPERLY DESIGNED AND CONDUCTED

Based on my experience at FDA and as a pharmacokineticist, it is my opinion that,

contrary to Core and Mutual’ criticisms, King’ clinical studies -- Studies 10 1, 103, 105 and 106 s s -- were designed and conducted in a scientifically appropriate manner, fully consistent with FDA’ Guidance for Industry, Food-Effect Bioavailability and Fed Bioequivalence Studies, s FDA, CDER (Dec. 2002), and the Agency’ predecessor draft guidance. The pharmaceutical s industry commonly conducts food-effect studies in accordance with this guidance and data generated by single-dose studies investigating the effects of a standardized high fat meal are commonly described in prescription drug product labeling. Likewise, FDA and the pharmaceutical industry have endorsed the use of me&analyses for pooling and analyzing data from two or more studies. As such, adherence to FDA’ guidance provides no basis to criticize s the studies or their results. A. 42. The Use of a Standardized High-Fat Meal To Determine the Existence of a Food Effect Is Appropriate Core and Mutual theorize that different studies investigating the effects of meals other

than the standardized high fat meal would reveal that co-administration of metaxalone with food of different compositions has varying effects on the bioavailability of metaxalone. From this, - 14-

Core and Mutual conclude that the pharmacokinetic information may properly be omitted from the labeling for generic metaxalone. This conclusion, however, is flawed. In the absence of clinical data, it is impossible to conclude that the fed-state bioavailability of metaxalone would be affected differently by the administration of meals other than the standardized high-fat meal used in the clinical studies. Contrary to the assertions made by Core and Mutual, the use of the standardized high fat meal does not undermine the results of the clinical studies designed to assessthe effect of food on the bioavailability of metaxalone in any way. 43. In fact, the FDA guidelines recommend that food-effect bioavailability studies and fed

bioequivalence studies be conducted using the standardized high-fat meal. Core and Mutual do not dispute that the fed bioequivalency requirement that for generic me&alone is satisfied only

by conducting clinical studies that utilize the standardized high fat meal. Indeed, if the caloric breakdown of the meal significantly differs from the prescribed standardized high-fat meal, a scientific rationale for the difference is required. 44. Moreover, although the FDA allows New Drug Applicants to conduct food-effect

bioavailability studies using meals that differ from the standardized high fat meal for exploratory or label purposes, the FDA requires that one of the meals investigated be the standardized highfat meal. FDA has recognized that food-effect studies utilizing the standardized high-fat meal provide important pharmacokinetic data that should be incorporated into labeling. As discussed above, based on Studies 101 and 103, FDA required the conduct of fed studies utilizing the standardized high fat meal, and included the pharmacokinetic data that resulted from the studies in the SkelaxinB labeling.

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45.

Thus, in my opinion, any suggestion that the utilization of the high-fat meal renders the

clinical studies useless and of no practical or clinical import is contrary to FDA policy and unjustified. In particular, it is my opinion that this alleged defect in the clinical study protocol is certainly no basis for asserting that the omission of the pharmacokinetic data from the clinical studies would be proper. 46. The fallacy of the criticism is further compounded by the lack of any actual clinical data

suggesting that the fed-state bioavailability of metaxalone would differ when administered with a meal other than the standardized high-fat meal. Co-administration with different meals may OP may not impact bioavailability differently than co-administration with the standard high fat meal. The bioavailability of different drugs is impacted differently by co-administration with various types of meals (as the exhibits to the Core and Mutual submissions indicate), and absent data from studies conducted on metaxalone, it is impossible to predict how, if at all, the bioavailability of metaxalone would differ when co-administered with various types of meals. 47. Core and Mutual also err in assuming that the possibihty that bioavailability may be

impacted differently when metaxalone is co-administered with different types of meals means that information on known food-effects should be omitted from generic metaxalone labeling. Contrary to Core and Mutual’ suggestion, as discussed above, FDA has never required that all s possible food effects be clinically investigated before information about known food effects is incorporated into product labeling. B. 48. The Use of a Single Dose Study To Determine the Existence of a Food Effect Is Appropriate Core and its expert, Dr. Bass, also criticize King’ use of single-dose studies, arguing that s

at steady-state, the observed food effects would be non-existent or minimal. This criticism is - 16-

also scientifically unsupported and unjustified. FDA’ food effect guidance recommends use of s a single-dose design. The pharmaceutical industry routinely conducts food-effect studies in accordance with this guidance and data generated from single-dose studies are commonly described in prescription drug product labeling. Moreover, bioequivalence studies submitted by generic drug companies (including those seeking to market generic versions of SkelaxinB) are also required by FDA to be single dose studies. The criticism of the use of a single dose study for assessing food-effects is contrary to FDA rationale for requiring the single dose study. C. 49. The Clinical Studies Are Properly Sized and The Use of a Meta-Analysis To Investigate the Effects of Age and Gender Is Appropriate Core and Mutual criticize the number of subjects included in each of the clinical studies

designed to assessthe effects of food, age, and gender on the bioavailability of SkelaxinB. Based on my review, the studies were appropriately sized, given their purpose. Moreover, in my experience, studies conducted to investigate the impact of food, age, or gender on bioavailability typically include 16-45 patients, which is fully consistent with Studies 101, 103, 105 and 106. I note that bioavailability studies submitted by generic drug companies, such as Core and Mutual, in support of their ANDAs typically do not include a greater number of subjects than did the King studies, and indeed often include fewer subjects. In sum, Core and Mutual’ criticism is s baseless. The studies were sized appropriately. 50. In connection with their criticism of the number of subjects in the clinical studies, Core

and Mutual also criticize the utilization of a meta-analysis to assessthe age and gender effects. Based on my experience at FDA and as a pharmacokineticist, a meta-analysis is commonly used and is an appropriate tool to evaluate the data from two or more clinical studies bearing on the

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same question. In addition, meta-an~ysesprovide powmfiJ measwesof effects that might otherwise go unnoticed.
31.

Contrary to the criticisms asserted Core and MutuaI, it is my opinion that it was by

entirely appropriateto pool the datafmm Studies 101,103,lOS and 106 to determinethe effects of age and gender bn the bioavailability of SkalaximBin the fed and fasted s&h%- Endeed, King’ s use of the m&-analysis obviatesCare and Mutual’ statedconcernabout the size of King’ s s studies.

52.

In sum, the results of King’ studiesdesignedto BSS(?SS ef&cts af food, age, and s the

gendershould not be omitted from the labeling for generic versions 5fSkehxiu.Q Based an my experienceat FDA and as a pharmacokhticist, it is my opinion that such phamnacokinetic data shouid not be omitted from labeling, pa&ularJy in the absenceof any clinical data that show that changesin bioavailabifity are immaterial to safety and efficacy. It is also my opinion that the argumentsCore and Mutual have presentedin supportof their position that the pharmacokiietic data can be removedfrom the labeling for generic rne&xaloneproducts rare without suppclrtand without merit.

I dedare under the penalty of perjury under the laws of the United Statesof America that the foregoing is true and correct.

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CURRICULlJfl VnTAE

JEROME P. SKELLY,
9321 Cora? Alexandria,
Lane

Ph.D.
22309

Virginia

Office (703) 360-8418 Tel. Office (703) 360-8328 Fax. E-mail Jeromepskelly@lSN.com

DATE OF BIRTH: PlACE OF 5IR7H:

December

15,

1932 I7 7 inois

Vermi 7 7 ion Married,

Township,

MARITAL STATUS: EDLK;r\TII)IN:

Three

Children

1
B. 5. Chemistry M. S. Chemistry Ph. 5. Chemistry

Detroit,

Wayne State University Michigan

1964
(Biochem.) 2964-66 1966-69

University of California Co77ege of Pharmacy Medica Center San Francisco, Cl&. Carnegie-Me77on University Pittsburgh, Penn. Senior States Char7ottesvi7 PRESEKiPosI7ToMs President-E7ect

Biophamaceutics Senior Executive Training

1974-75
1985

United

Executive Institute Goverment
7e, Virginia

Senior

Executive

Training

1986

American Association
Pbamaceutical Jerome Phifip

of PharmaceuticaIScientists

10/03-Present
l/93-Present

Consut tant Ske’ lly, Ph.D.,

Ltd.

Chairman of the Board of Directors Founding Officer & Member, Board of Directors Phamtaceutica7 Qua7 ity Research Institute Pas t-Gmnodore Pkmnt Vernon Yacht C7ub Alexandria, Virginia Pro fessor o f Biophatmaceut Division of Eiophatmaceutics College of Pharmacy llnivemity of Cincinnati Associate - Westfie7d Wi7 tan, Cbnneticut Strategic Ve’ lquest Hopkinton, Projects its (Adjunct)

3/02-lo/O3
6/99-IO-03

H/98-Present

5/93-Present LiC f/03-Present

Partners,

Advisory Board Cororation Massacheusetts Consu7 tancy Board

6/00-Present

I.D.E.

Group

Is tanbu 7, Turkey

5/99-Present

i a\ !

PREVIOUS EXPERIENCE :

Connnodore CEO & Chairman of Board Mount Vernon Yacht Club Alexandria, Virginia

of Directors 11,‘ 98-11/2000

Executive Vice President Scientific and Requ7atory Affairs Cbpley Pharmaceutica’ l Inc. Bes ton, Massachusetts Scientific American Cincinnati, Advisory Biovail Toronto, Advisory Ohio Beard of Directors Research Corporation Canada States Board

1994-1997

Pharmaceutical

Internationa7
1995-2002

z/93-1/95

Senior Executive Service Government of the United Washington, D. C. Deputy Office Center

5\86-1\93

Director of Research Resources for Drug Eva7uation and Research, and Associate Director for Science Office of Generic Drugs Center for Drug Evaluation and Research, Acting Director Office of Research Resources Center for Drug Evaluation and Research food and Drug Ackinistration * Chaiman CDER combined Food and Drug Federa Campaign Adiwinistration

FDA

S/88-1/93

FDA

10/90-6/92

S/88-4/91

1989

Director
Division of Biophamaceutics Center for Drug Evaluation Food and Drug Administration and Research 1/83-S/88 Program 8/83-l/93

Program Manager Biophamaceutics Research and Review Center for Drugs and Bioloqics Food and Drug A&inistration Deputy Director Division of Biophamaceutics Center for Drugs and Bioloqics Food and Drug Administration *
This

11/79-l/83

was the first and only CDER campaign eve over a 20 year period through 1992) (i-e., to attain or surpass its goal.

Acting

Director

Field

Science

Support
7/79-H/79

EDRO/FD Chief, Pharmacokinetics and Riopharmaceutics Branches Division of Riopharmaceutics Bureau of Drugs/FDA

1975-1980

Post Doctoraf

Scholar
School of Pharmacy Medica Center 1974-1975 and Research 1972-1975 and 1968-1972

University of California, University of California San Francisco, California

Chief, C7inica7 Research Branch, Supervisor, Division of C7inica7 Bureau of Drugs/FDA
Chemist, Division of Metabo’ lic Endocrine Drugs Bureau of Drugs/FDA Research and Teaching Wayne State University lktroi t, Michigan . Laboratory Chief Michigan Abrasive Detroit, Michigan Assistant

1963-1968

Company 1959-1963

PROFESSIDNAL AClTWTIES: MEMBER OF EDTToRIAl BOARDS: 3ourna7 of Clinical Pharmacology American Col’ lege of C7inica7 Pharmaco’ logy 1990-2002 Philadelphia, Pennsylivania C7inica7 Research and Regu7atory Wrce7 Dekker, Inc. Hontice770, New York Edi toria Review Board Harce7 Dekker, Inc. New York, New York InternationaI Editoria7 Advisory Board Encyc7opedia of Pharmaceutica’ l Technofogy, New York, New York .XXJRNAl REVIEWER (Ocs.1: Pharmaceu t ica 7 Research American Association of New York, London Journa 1 of Pharmaceutics American Pharmaceutica7 Washington, D. C. Pharmaceuticajl 7 SC iences Association 2nd Edition Affairs

Scientists

Pharmaceutical Development and Techno7ogy Pharmaceutica7 Technology Section, AAPS New York, New York

4
AWARDS/COMMENDATIONS: Good Conduct U.S. Army
Medal

1958 (Professiona Citation) 2958 1963

Letter of Commendation, U.S. Army Letter of Comnendation Michigan Abrasive Co.

E‘ lected to Phi Lambda Upsi7on (Chemistry Honors Society) Qua’ lity Performance Raises Outstanding Perfumauce fwluatims Outstanding Performance Eva7uations Senior Executive Service Bonus Letter of Comendation: Research and Faci7ity P’ lanning Executive Director for Regiona Food & Drug Adhrinistration (Civi7 (Senior Service):1982,1983,1985 Executive Service)

2967 1973 & 1979 & 1987 1990 : 1990

Operations
1979

Award of Merit, (FDA’ Highest s Award) ‘ *For Exceptiona Achievement in Repeatesly Providing Scientific Support Leading to Successfu? Litigation Against Fims Marketing Unapproved Drug Products” Food and Drug Acbrtinistration

Expert 1981

- Equa7 Dpporruni ty Achievement Award Pub7 ic hea7th Service “For outstanding Leadership in Recruitmenr & Training of Personnel & Outstanding Achievement in Fostering Equal Employment opportunity in the Pub’ lic Hea’ lrh Service”

1986

- Equa7 Opportunity Achievement Award Pub7 ic health Service “For Providing Equa7 Consideration of High’ ly Qualified Staff Fe7lows by Resolving Extremely Difficu’ lr Personne’ l Issues which Fostered 1988 lInequa Remuneration and Hindered Promotion”. Connrissioners Speciat Citation ‘ As a Rember of the ‘ CWM Guidance Manuaf Taskforce ’, Creating Effecienr & Effective App’ licarion Development for the genefir of FDA, Imiustry and the Pubjric”. Food and Drug Ahrinisrration Certificate of Appreciation Nationa Drug Manufacturing Food and Drug Administration Drug Qua'lity Control

1993

1996
Standards to the for 1996 AAPS and
Nov. *

Recognition Award “For His Leadership in the GIoba7ixation of Qua7ity the Phanaaceutica’ i Sciences and His Devoted Service Advancement of Pharmaceutica7 Science”. American Association Indian Phamaceutica7 Scientists Distinquished Service Award “In recognition of His Scho7arly Effort the Pharmaceutica’ l Sciences. American Association of Pharmaceutica7 Toronto, Canada in Advancing Scientists

5 WVERNMENT CLEARANCE Full Fie7d Investigation: Eligibfe to Occupy Critica 200-C iYedica7 Inspection Sensitive Credentia'fs Position l/79 l/79

-SERVICE: United States Army, Volunteer Letter of Commendation 10/56 to 10/B lo/58 10/58 1962

Good Conduct Meda7 Honorable Discharge PROFESSIONAL SOUETY MEHBERSHIPS: FELLOW: American Association of Pharmaceutica'l Scientists Scientists
American Co77ege ofClinica7 Pharmaso?ogy dmericxan Association of Indian Pharmaceutical

LIFE MEMl3ER: Phi Lambda Upsi'lon (Chemistry Honors Society) SUSTAINING MEMt3ER GFIARTER AND MEMBER: American Association FOA CHARTER MEMBER: Research Society of America - Sigma Xi FUA Alumni Association OTHERPIEMlJERSHIPS: Ameciacn Cb77ege of Clinica
American Chemica7 Society

of Pharmaceutica7 Scientists

Pharmacology

KEY CQMMITTEES: Academic and Nationa Center/Institute: 2002-2003 6,'99-2003

Chairman of Board Of Directors Member of the Board of Directors Pharmaceutical Product Quality Research Institute Arfington, Virginia Center - Compendia7 Po7icy Faci7itation Croup Center for Drug Eva7uation & Research, Food and Drug Administration

1990-1993

6
Sponsoring University CDER, FDA Professor Gordon Amidon Officer, of Michigan, Sabbatica7 @ FDA Convention 1990

19961991

USP 1990 Quinquennia7 FDA Representative Washington, V. C.

International Industrial Pharmacy Conference University of Texas, School of Pharmacy Conference Comi ttee (Annual) Austin, Texas Advisory Comi t tee Carnegie Mel ion University Senior Executive Seminar Pittsburgh , Pennsylvania Consu’ ltant Division Nationa Japanese Osaka & on Controlled Re’ lease Drugs of Drugs Institute of Hygenic Science Ministry of Health and We7fare Tokyo, Japan

1977-1993

1985-1992

1987-1990

Promotion Review Con&tree Fu7 7 Professor Solomon Stavchanski School of Pharmacy University of Texas Austin, Texas Research Nationa Rockvi7le, Scientist Institute maryland Promotion Panels of Drug Abuse

1987

1983-1985

Research Scientist Promotion Panels Exec. Dir. Reg. Qper. Research Centers Rockville, mary7and Research Scientist Promotion Panels National Center for Toxicological Research Pine Bluff, Arkansas Proatotion (Tenured) Review Gmittee Assoc. Prof. Betty Ann Hoerner Schoo7 of Pharmacy University of California San Francisco, California Wayne State University Alumni Assoc. Committee Washington D. C. Chapter International: AAPS Globalization FDA Alumni Association Comittee - International Committee

1980-1982

‘ 1979-1981

1980

1969-1978

2003-Present ZOOZ-Present

7 Committee Member BioInternationa? '94 FDA, HPB, EC Regulatory Munich, Germany
Committee Member

Bodies, FIP, & AAPS

1993-1994

BioInternationa7 '92 Food and Drug Administration, Canadian Health Protection Branch, latory Bodies European Commission Regu’ Federation Internationale Pharmaceutique, % American Association of Pharmaceutics? Scientists Bad Homberg/Frankfort, Germany European Comunity Ad Hoc Comittee Sate77ite Meeting On the Definition of Bioavailability Federation Internationa’ l Pharmaceutique Munich, Germany Health Protection Branch Laboratories Site Visit Comittee, Department of Health and Welfare Ottawa, Canada
Cbmi t tee Meinber

1991-1992

1989

1989

BioInternationa7 '89 Canadian ffea7th Protection Branch Foal and Drug A&inistration/American Phamaceutica'l Scientists

Association

of

1988-89

International Advisory Scientific Program+? Comittee Third International Conference on Drug Absorption Edinburgh, Scotland Interna tiona7 Advisory Board Snternationa7 Conference of Pharm. Services and Clinical Phamaco'logy Jerusalem, Israe #ember Internationa'l Pharmaceutica7 Scientific Affairs Task Force American Association of Pharmaceutical Ar'lington, Virginia Collaboration, Labora tory and Consu7tant Division of Drugs Nationa Institute of Hygenic Science FIinistry of lfea7th and Welfare Osaka and Tokyo, Japan Corresponding klember Working Group, Dissofution Testing Federation Internationa'le Pharmaceutique Saskatoon, Sask., Canada Consu7 tant, World Hea7th Organization U0DCAR National Organization on Drugs Dokkai, Cairo, Egypt

1988

1988

Scientists

1988

1987-1991

2986-1989

1986

8
Professional : Fe77ows Virginia Election Committee AAPS 2003 AAPS 2002-2003 ‘ Finally a Reality ,8 AAPS 2003

Chairman: Arl inqton, Governance Arl inqton,

Task Force Virginia

Arlington,

Fe7 ‘ lows Task Force Virginia

Chairwan % Planning Committee Member Workshop of “The Paperless Laboratory: AAPS & Parenteral Drug Association Arlington, Virginia Executive Regulatory Chairman American Fellows American Chairman, Regulatory Outside Fe7lows Committee Affairs Section AAPS

June,

2002

1993 -2002
Scientists 1995-96 1993-94 1996-2001 1993-94 1997-2001 1997-1998 l/92-1/92

Fellows E7ection Comittee Association of Pharmaceutica’ l Election

Association Section, Reviewer
Se7ection

Committee of Pharmaceutical Committee

Scientists

Fe1 Pows Nominating

AAPS
Gnnwittee Large - AAPS

Executive CounciI Elected #ember at

Planning Conanittee Hember and Session Chair Bioavai7abi7ity and Bioequivalence Sywposim Drug Information Association Rockvi’ le, l’ Maryland Vice President for American Association

9/94 1993

Search Comittee Science: of Pharmaceutical Scientists
Systems

Organizer and Comittee Hember Scale-Up of Liquid & Sentisolid Disperse AAPS-FDA Workshop Virginia Ar’ lington, Chairman Scale-Up and Gmmnittee of So7id Ora Mentber Controlled Re’ lease

1993

Dosage Forms
9/92

AAFS-FDA Workshop Arl inqton, Virginia
Chairman Pharmacokinetics, Pharmacodynanics, & Drug Hetabol American Association of Pharmaceutical Scientists A7exandria, Virginia Co-Chairman and Committee Member Sca’ le-Up of Solid Ural Immediate Re7ease AAPS-FDA Workshop Ar7 ington, Virginia Dosage

ism Section
I/91 -l/92

Form 1991

9
Chairman of Sponsoring Section and Committee Member OPEN FORUM-I ’ PPDN ‘ “Pharmacokinetics/Pharmacodynamics, Where is it Going?” Pharmacokinetics, Pharmacodynamics, & Drug Metabolism Section American Association of Pharmaceutica’ l Scientists Washington, D.C. Co-Chairman and Committee flember Integration of Pharmacodynamics Pharmacokinetics in Rationa Drug Development - Conference AAPS/FDA/%SCPT - Ar7 ington, Virginia Committee Member and Consensus Session Chairman Ana’ lytica? Methods Va7idation Bioavai7abi7ity, Bioequiva7ence and Pharmacokinetics Studies-Conference AAPS/FDA/FIPfiPl3/ADAC American Association Task Force on Batch Chairman Elect, fharmacokinetics, of Pharmaceutica’ l Science Size and Bioavai7abi7ity & Toxicokinetics 1991

1991

1990 1990-1991 l/90-12/90

& Member of Executive Committee - AAPS Pharmacodynamics, Drug Metabo7ism Section Scientists

fe77ows Se’ lection Committee American Association of Pharmaceutica’ l A7exandria, Virginia

1990 & 1990

Session Chairman and Conmi ttee Advisor Princip’ les and Criteria for the Deve7opment Optimization of Topical Drug Products FDA/AAPS - Arlington, Virginia Chairman: Fe77ows Nomination Committee Phannacokinetics, Pharmacodynamics and Drug Wetabo’ lism Section, AAPS

1990

Use of Anima’ ls as Substitutes for Humans in Dra7 Bioavai7abi7ity and Bioequiva7ence Studies Division of Biophannaceutics, FDA and PMA tirkshop Cosponsor and P7anning Committee In-vim Percutaneous Penetration/Absorption fDA/XA?S/ACSF Vice Chairman Pharmacokinetics, Drug Metabolism Pharmacodynamics Section, AAPS and Member

1989

1989

l/89-12/89 Workshop 1989

Facilitator PI%4 Division of Biopharmaceutics Pharmacokinetics of Metabo'lites Bethesda, Mary7and

Workshop Chairman and Committee Member Contro77ed Re7ease/Rodified Re’ lease Dosage Forms, In-Vivo and In-Vitro Testing FDA/AAPS/USP/FIP Executive Connrittee Pharmacokinetics, Pharmacodynamics Metabo7ism (PPDM) Section, AAPS and Drug

2988

9/87-12/92

10 American Association of Pharmaceutics? Scientists 1989 Annual Meeting Program Planning Committee Chairman, Strategic P7anning Committee: Pharmacokinet its, Pharmacodynamics and Drug Metabolism Section, AAPS Co-Chairman, Program Committee Pharmacokinetics, Pharmacodynamics % Drug Metabolism Section AAPS Nationa Meeting. Atlanta,Ceorgia Faci7itator Division of Biopharmaceutics (FDA>- and (PMA), Workshop Drug Eletabo7ism Section Role of Pharmacokinetics & Metabo'lites in Development of Racemic Drugs Bethesda, Mary'land Ad Hoc Committee on Drugs in the E7der7y and Testing the Pharmacokinetics Screen Am. Sot. C7in. Pharm. Therap. Rockvi?7e, Md. Committee on Regulatory and Government Affairs Control Zed Release Society Co-Chairman and Co-Sponsor Symposium Planning Pharmacokinetics of Antibiotic and Anti-cancer _ FDA/AAPS/ACCP, AAPS ffationa7 Meeting Boston, Massachusetts Workshop P’ lanning Committee and Co-Sponsor: Targeted Drug De7 i very Sys terns EDA/AAPS/ACW AAPS Nationa Meeting Boston, Massachusetts P7anning Consnittee and Co-Sponsor: Principfes of Practices of In Vitro Percutaneous Studies: Re’ tevance to Bioavai7abi7ity and Bioequiva7ence AAPS 1st Nationa Meeting in Washington, D.C. FDA/AAPS/University ofC'a7ifornia
kbrkshop

g/88-10/89

9/88-l/90

9/88-M/89

1988

1987-1989 1986-1988

Committee: Agents
1987

1987

1986

Co-Chairman and Workshop Program P'lanning Committee: Contro77ed Re'lease Dosage Forms: '('Issues and Controversies" ASCY7/FDA/DlA and APS P‘ lanning Gmsnittee Biopharntaceutics Considerations Drug Informat ion Association Editorial C7inica7 Board Research Practices in IND and NDA Workshop

1985

1985
1985-1990 1984-1985

and Drug Regu7atory Affairs

Education Committee: American Co7lege of C7inica7 Pharmacology
Admissions Commit tee: Research Society of America FDA Section

1972-1973

Food and Drug Administration: CANDAGuidance Manual Task Force WER flember
Food and Drug Administration 1992-1993

Co-Chairman
CANDA-Biopharmaceutics

WER-PMA Taskforce Food & Drug Administration & Pharmaceutical Manufacturers Assoc. Pharvnacokinetics FeTlowship Committee Center for Drug Evaluation and Research Food and Drug Administration Center for Drug Eva7uation and Research Counci7 Equal Emp'loyment Opportunities Advisory Food and Drug Administration
Center for Drug Eva'luation and Research Food and Drug Administration* Co-Chair

1990 - 1992

3[990-1991

1989-1990

Staff

Co77ege Executive Coannittee

1988-1991

Center for Drug Evairuation and Research United States Pharmacopoea Policy Faci7itation Group
WER-FDA Compendia7 Liaison Committee Center for Drug EvaTuation and Research

1990-1993

Food and Drug Administration
Chairman Combined Federal Campaign Center for Drug Eva’ luation

1990-1993

and Research 1989

Food & Drug Administration WER - Staff and Po7icy Committee Center for Drug Eva’ luation and Research food & Drug AcMnistration
Research Eva’ luation Committee Center for Drug Evaluation and Research

5/88-1992

Food 8 Drug Adininistration
Research Steering Cmmittee Center for Drug Eva’ luation Food & Drug Adntinistration and Research

l/89-11/90

S/88-12/%8 1985-1986

PMA/FDA Cotmnittee
For Improved Comnunica t ions Fe7lowship

Chairman
Pharmacokinetics

Center for Drugs and Bio7ogics Food & Drug Administration

2985-1990

12
Retrospective Regulation Review Bioavailability/Bioequiva7ence Regulations Center for Drugs and Bio’ logics Food & Drug Administration Drug Disso7ution Committee Division of Biopharmaceutics Bureau of Drugs Food & Drug Adininistration Merit Pay Board Office of Drugs Bureau of Drugs Food % Drug Administration Compendia7 Liaison Staff Bureau of Drugs Food & Drug Administration Information Systems Users Bureau of Drugs Food % Drug Administration Bioequiva7ence/Bioavai?ability Regu’ lat ion Deve7opment Bureau of Drugs Food & Drug Administration Theophy7 7 ine Task Force Bureau of Drugs Food 7 Drug Administration Statistica Subcommittee, Compendia7 Liaison Staff Bureau of Drugs Food & Drug Administration Project Officer, Bioavai’ lability/Bioequiva7ence Division of Biopharmaceutics Bureau of Drugs Food & Drug Administration Project Contro’ i Officer Digoxin Bioavai7abi7 i ty Bureau of Medicine Food B Drug Administration Chairman, Bureau of Drugs Bioavai7abi7ity Bureau of Medicine Food & Drug Administration Member: Eioavai7abi7ity Committee Bureau of Medicine Food & Drug Ahinistration Committee Monograph Task Force Commit tee

1983-1984

1982-1984

1981-1982

1977-1980

1975-1979

Task Force 1975-2979

1976-1978

1977-1978

1975-1976

1972-1974

1973-1974

1972-1974

13
PROIECT OFFICER/FDA Bioavai7abi7ity Marketed Drugs Testing of Selected CONTRACTS John Wagner, Ph.D. Distinguished Professor University of Michigan Ann Arbor, Michigan John Wood, Ph. D. Pro fessor Of Pharmacy VA Ccnmnonwea7 th Un, Richmond, Virginia American Society for C7inica7 Pharmaco’ logy Therapeutics. Medica? Tulane University New Or7eans, Louisianna University of Ca7ifornia Schoo7 of Pharmacy San Francisco, Ca7ifornia Sidney Riege7man, Ph.D. Prufessor and Chairman Department of Pharmacy University of Ca7 i fornia San Francisco, Ca7ifornia Drugs Marvin Meyer, Ph.D. Professor of Pharmacy and Asst Dean-S&x7 Pharmacy University of Tennessee Memphis, Tennessee System Cannon Laboratories Reading, Pennsy’ lvania Stanford Research Inst. Pa70 Al to, Ca’ lifornia Ra7ph Shangraw, Ph.D. Pro fessor, & Larry Augsberger, Ph. D. Professor of Pharmacy University of MarySand ETa7 timore, PIaryland Bureau Bureau of Foods and of Medicine, FDA

Digoxin

Bioavai7ability

C’ linica’ l Therapeu

Pharmaco’ logy and t its Symposium

and Sch

Workshop on Biochemical to Oinical Pharmaco’ logy

Approaches

Plethodology Bioavai7abi7ity

Development Testing

and

Bioequiva7ence

Survey

of Sefected

Intramuscufar

Injection

as a Drug

Delivery

c” Labe’ led Giucocorticoid and Bioavai7abi7ity
Co1 laborative Agreement Research Faci7 i ty

Synthesis

with

a Pharmaceutical

Aminoacidureas Inherited Disorders

of Metabolism

14

JUDICIAALPROCEEDINGS FOODAND #RUGADMINISTRATION

Scientific

Consu’ tant l

United States District Court District of New Jersey United States of America
vs

Phamadyne Laboratories and Bernard A. Bedrick Marketing of Unapproved Drugs Spring 1980 Consultant

Scientific

*United States

District Court District of New Jersey **hi ted States of America

vs
Premo Pharmaceut ica 7 Laiwra tories,

Inc.

and Seymour N. Blackman Sumner 1980
Scientific Consultant

***United
Professional

States of America vs

Veterinary Laboratories d 3-78 Civ. 192 June 6, 1979

Scientific Affidavit Ora
Withdrawa

Consultant

filed on the matter of: Proteo'lytic Enzymes
of New Drug Applications Hay 28, 1980

* ** ***

Case eventuaf'ly Affidavit fi'led For the District

reso7ved in Supreme Court. to the United States of Minnesota. District Court Medicine.

As Specia7 Consu7tant to Bureau of Veterinary

SUPAC: Impact & cha77enges AAiPS Dinner Meeting Morristown, N. 3.

PRESENTATIONS: Faced by Industry Apri7, lab, JIune, 2003 2002

Summary of Regu7atory Issues Facing the Paperless Co-Chair, Moderator, and Sponsor AAPS-POA Workshop ‘ The Paperless Laboratory’ :‘ Fina’ ly a Rea7ity” Arl ington, Va. Stream’ lining Drug Development ‘ Bridgining the US - European Harrison Clinica Research Philade’ iphia, Pennsylvania Co-Moderator “ FDA Speaks - We Listen” ‘ American Co77ege of C7inical Annua’ Meetring l Symposium Tysons Corner, Virginia - Asian Cap”

Apri 7, 2002

October Pharmacology

, 2001

Scale-Up & Post Approva’ Changes l International Institute of Research A’ lexandria, Virginia In-Viva/In-Vitro Corre’ lations Second Pharmaceutical Sciences Conference Assiut University: Assiut, Egypt Scale-Up & Post Approva7 Changes Immediate Retease & Modified Retease Drug Second Pharmaceutica’ l Sciences Conference Assiut University: Assiut, Egypt SUPAC - A Short Products

6-22-2000

Mar. 8,

2000

Mar.

9,

2009

Aamrican Association

Course: of

November, Pharmaceutical Sciences

1999

Annual Meeting New Orleans, Louisianna Regulatory Issues & Update Where are We Headed? Phoenix C7 inical Program “Design for the New Mi’ llenium” San francisco, California Regulatroy Issues & Update Where are We Headed? Newark New Jersey Moderator: Individua’ l Phoenix Internationa7 Montrea 7, Quebec Bioequiva7ence Symposium Oct. 18, 1999

Oct.

14,

1999

lune,

1999

Scientific & Regulatory Support - SUPAC Center for Professional Advancement New Brunswick, New fersey Chair, Drug De’ livery Session Phoenix Laboratory 10th Annua7 Mentrea7, Canada Symposium

June,

1999

June,

1999

16
Sca’ le-Up & Post Approval Formu7ations Forum Ur7ando, F7a. Changes March 1999

Switchabi7ity - Prescribabi 7 i ty! Is Required? What Pleasure of Bioequiva7ence Internationa7 Symposium Honoring Professor, Doctor hb7fgang Ritschel Cincinnati, Ohio Bioequivalence and/or In Vitro in Lieu of C7inical Efficacy University of Cincinnati Cincinnati, Ohio Sca’ le-Up and Post Approva’ l So7id Oral and Semi-So7id University of Cincinnati Cincinnati, Ohio Testing

11/l 3/98

U/12/98

Changes Percutaneous

11/12/98 Dosage Forms

Wi77 The PDA A17ow The Use of In-Vitro DissoTution as a Surrogate of C7inica7 Efficiacy? 38th Annual Eastern Pharmaceutica7 Techno’ logy Meeting Whippany, New Jersey Regu7atory and Industria7 Considerations, and Analytica Requirements for SUPAC Institute for App7ied Phamaceutica’ l Science East Brunswick, New Jersey Regulatory Documentation and Testing Requirements for SUPAC Institute for Applied Pharmaceutical East Brunswick, New Jersey Regulatory Requirwnt for Approva7 Generic Percutaneous Dosage forms Institute for Applied Pharuzaceutica7 East Brunswick, New Jersey In- Vi vo - In Vitro Corre7ations Co77ege of Pharmacy University of Connecticut Storrs , Connet icu t Drug Approval ! Future Aspects of FDA Quo Vadis Medicamentum Bobeheim, Germany FDA Requirements for Sca7e-Up, Site Formu’ lation ChangesImediate Re’ lease Release Dosage Forms University of Cincinnati Cincinnati, Ohio Dermatopharataceutics and Changing Pharmacokinetic and Pharmocodynamic Topica Semi-So7id Dosage Forms University of Cincinnati Cincinnati, Ohio Transfer, and and Contro77ed

10/l 5’ 98

S/18/9%

S/18/98 Science of Science 9/97 5/‘ 19/98

4/97

11,‘ 96

Requirements for Studies for Testing

U/96

17 The Crises facing Science: Award Lecture American Association of Indian Pharmaceutical AAPS Annua7 Meeting Seattle, Washington
Bioavai7abi7ity, Bioequivaleffce Disso7ution: Biopharmaceutics National Drug Manufacturing and Quality Control FDA Field Inspectors Training Course DHHS - FDA - Univ. of Cincinnati Newark, New Jersey Drug

1 O/96 Scientists

8/96

Xndividua7 Bioequiva’ lence - Is it necessary? heneric Pharmaceutica'l Industry Assn - Science Committee
Newark, New Jersey Practical Aspects of Setting Specifications! Is the Tail Wagging the Dog? AAPS - Eastern Regional Meeting Newark, New 3ersey

8/96

6/96

Dissolution Testing of Polymorphic Forms Can In Vitro Studies Serve as a Substitute BioequivaYnce Testing? Philadelphia Pharmaceutica7 Forum3ef ferson House
Norristowm, New Jersey

12/95 for Human

Individua'i University Cincinnati,

Bioequiva7ence, of Cincinnati Ohio

and Highly

Variable

Drugs

m/95

Issues at The Cutting Edge of Science I&E vs Average Bioequivalence Ohio Cincinnati,
Basis of Regulation The Scientific The Impact of Academic Pharmacy on Research, Education, "A Tribute fo Prof. Ra'iph Shangraw" and Public Policy. University of Naryland 5a7 timre, Maryland

10195

4/9r

New Initiatives In Bioequivalence Assessment: Symposium on Current Cha77enges in Bioavai7abUity NAPMAnnual Meeting, Puerto Rico Co-Chair and Pana7ist Symposium on Proteins and Peptides AAPS & ACCP, Symposium and Frontiers Regu'latory
16 Annua?

Z/95

z/95 Series Regu'latory Viewpoint I/95

Eioavai7abi7ity/Interchangeabi7i$y:

Viewpoint

Eimo Nelsum

Turnberry

Isle

Resort.

Memoria7 Conference Aventura, Florida n/94 Regulations

Chair Evo'lution of Biotechno’ logy AAPS Annua7 Meeting San Diego, Ca7i forn ia

18 Co-Chair and Symposium Rapporteur Bioavi7abi7ity - Bioeguiva7ence Drug Information Symposium Rockville, Maryland Wor'ld Wide Problems 7th International Pharmaceutica7 Haccettepe University Ankara, Turkey
Member and Rapporteur, Bioequiva7ence: Quality Control Plunich, Germany Committee 9/94

9/94

Techno'logy Symposium

6/94

and Therapeutic

Surrogate
5/94

Potential Effects of Health Care Reform on the Pharmaceutics? Industry Fifth Annua? Symposium Phoenix Internationa7 Life Sciences Symposium Ffontreal, Canada

Rapporteur
Bioequivalence Quafity Contro’ t

s/94

and Therapeutic Surrogate Bio International Pfunich, Germany Sca7e-Up and Site of Manufacturing Changes: Adequacy of In-Vitro Tests as a Surrogate for In-Vivo North Carolina Discussion Group Research Triangle Park, North Caro7ina
Sca’ le-Up of So7id Ora Dosage Forms Pharmaceutical Techno'logy Conference At7antic City, New Jersey 3/94

Testing

9/93

Regulatory Assessment of Controlled Pharnt Tech Conference' Atlantic City, New Jersey

Re'lease Drugs

9/93

in Biopharmaceutics: In-Vitro/In-Vivo Correlations 'Scientific & Regu‘ iatory Considerations" University of Cincinnati

9/93

Batch size Scale-Up of So7id Ora University of Cincinnati Cincinnati, Ohio
Changes Requiring

Dosage Forms

9/93

6/93 Bioeguiva'lence Testing: 35th Annual Internationa'l Industrial Pharmaceutica7 Research Conference on Deve'lopment of Oral Dosage Forms for Poorly Bioavailab7e Drugs University of Wisconsin Lake Delton. Wisconsin

29
Evaluation of Regu7atory 2nd International Conf. Zurich, Switzerland Guidefine Based on Case Histories on Contro77ed Rejlease Dosage Forms. 6/93

In-Vitro/In-Vivo Corre7ations in Giopharmaceutics with Their Scientific and Regu7atory Implications 5th European Congress of Biopharmaceutics & Pharmacokinetics Brusse’ ls, Belgium How to Define a Panel of Vo7,unteers From Human Mcrosomes to Multinationa7 Registration An Integrated Approach to Human Pharmacokinetics Third Symposium Brusse’ Is, Belgium Regu7atory Assessment of Control 7ed Drug Pharmacy World Congress ‘ 92 Federation International@ Pharmaceutique, Mationa7 Congress of French Pharmacists Lyon, France Del ivery Ipharmex, and Fi’ ies: Deve’ lopment

4/93

m/92

m/92

Round Table Discussion Leader Gioequiva’ lence Issues of Oral 7y Acbninistered, Non-Systemical 7y Available Drugs AAPS 7th Annua7 Meeting San Antonio, Texas ffedicines, ProTonged Release/Immediate 1s Treatment the Same? Institute Pasteur de Lyon & Centre de Droit de La Sante Ger3and, France Re’ lease

m/92

6/92

P7enary Session Moderator and Panal ist In ternationa 7 Open Conference on and Bioequiva7ence Dissolution, Bioavai7abi7ity, Canadian Hea’ lth Protection Branch, USP and FDA Toronto, Canada Conference Conmi t tee - Bio Internationa7 Gioavailabi7ity - Bioequiva7ence & Phanaacokine tics Studies Conference. Panel Co-Chair and Panelist on ‘ Bioequivalence of Highly Variable Drugs Gad Homberg/Frankfort, Germany Case His tories : First Internationa? Conference Oral Controlled Dosage Forms 8er7 in, Germany on '92

6/92

II' 5/92

4/92 Oral Dosage Forms 4/92

Scale-Up of Inmediate Release, Solid Pharmaceutical Development Subsection PPIA Annual Meeting; Washington, D.C.

20
Pub7ic Standards

for Bioavai7abi7ity
Pharmacy

and Bioequiva7ence Conference z/92

#A

Perspective

Thirty-First Internationa7 Austin, Texas

Methods Va7idatton for Bioavaifabil ity and Bioequivalence Studies Second Symposium on Drug Bioavai7ability Santiago, Chi7e
Evaluation Regulatory Ba7 timore, of Controlled Requ irmen ts Maryland Re7ease Dosage Forms - Contro77ed Re’ lease Symposium

Anafytica?

1991

1991
and Wortd Standards 1991

Session Co-Chairman Bioavailabil ity and Bioequivalence Pharmacy World Congress - FIP Washington, 0. C.

Shah, V. P. and Ske77y, J. P. Regu’ tatory Requirements for Qua7ity Contro7 and Assessment of Bioavailabi7ity and Bioequiva7ence Pharmacy World Congress - FIP; Washington, 0. C. FDA &&de7 ines for Topical and Transdermat Pham. Tech. Conference: New York, N. Y. System

1991
1991

Anafytica’ l
Austra7ian

Adelaide,
Symposium Australian

Methods Va7idation and Stability Phatmaceutica7 Science Association Australia Sumation and Commentary Phamaceutica’ l Science Association Australia

Studies 2991

Ade7aide,

1991

The ClER Research Program Therapeutic Goods Adlninis tra tion Canberra, Australia U S Drug Approva7 Therapeutic Gwds Process: Sea Change or Ahinistration Temporary Turbu7ence

1991

Canberra,

Austral

ia
Workshop Drug - II

1991

Session Chaiman and Pane’ list Dermato’ logica7 Therapeutic Products Ar7 ington, Virginia - Dra7 Regu7atory Issues North Carol ina Discussion Contro7 Group led

1991 Delivery

Ra’ leigh,

North Carol ina

1991

and Committee Member kbrkshop on Analytica Va’ iidation Arlington, Virginia AAPS-FDA.

Session Chairman

1990

21
Biopharmaceutics and Clinical Pharmacology of Non-Systemically Available G. I. Drugs: Regulatory Concerns, AAPS 5th Annual Meeting Las Vegas, Nevada
k?feFefKe Preparations for Bioavai?abil Drug Registration in Europe: Update and Trends for the Future. Brussels, Belgium

1990

ity

Studies m/90

Sample Preparations for Dissolution Media Prior Su. 5. Y., Shiu, G. K., FAESS Meeting Cleveland, Ohio

Several Drugs in Serum and to Liquid Chromatographic Analysis and Skelly, 3. P. m/90

A Rode? for Predicting Drug Isomer Plasma Levels from Oral Controlled Release Dosage forms: Application to (+) and (-) Propranolol Rose, S., Leesman, G., Shah, V., Skelly, J. P.,Amidon. Controlled Release Society National Meeting Rena, Nevada Regulatory Considerations for Scale-Up of Controlled Release Products: Shah. V. P., and Skelly, J. P. Controlled Release Society National Meeting Reno , Nevada Effect of In AAPS Eastern New Brunswick, Vitro Specifications Regional Neeting New Jersey on In Vivo Product

C. 6/90

6/90 Performance 6/90

Regulatory Issues of Controlled Baweia. R., and Skelly, J. P. RAPS Nidwest Regional Meeting Chicago, I? 7 inois

Release

Products s/90

AAPS/FDA/SPS Workshop : Principles and Criteria Development and optimization of Topical Products AFT ington, Virginia In Vitro Dissolution Testing: Food and Drug Administration Seattle, Washington Oral Controlled Release DFUg: Baweia. R., and Skelly, 1. P. Professional Seminar Institute Woodcliff Lake, New Jersey Regulatory View

3/90

z/90

#/89

Report ContFo??ed Release Dosage Forms Workshop “Issues and Controversies”. Controlled Release/Modified Release Dosage Forms In Vivo and In Vitro Testing - Workshop Washington, D, C,

U/88

22
Regulatory Concerns in Control led Sciences U/88 Seminar U/88 Studies m/88

Release Drug Product Approval National Institute of Hygenic Tokyo, 3apan

National Institute of Hygienic Science Evaluation of Dosage Form Design Controlled Release Drug Products Osaka, lapan

Use of Animals
Universidad International Santiago,

in Lieu of Humans In Bioequiva7ence De Chile Symposium on Drug Rioavailability Chile
Methods for the Re’ tease Dosage on Drug Forms

Development of In Vitro Eva7uation of Contro77ed Universidad De Chile International Symposium Santiago, Chile Bioavailabi7ity

Bioavailability ro/as

and Bioequivalance De Chile Symposium Chi7e on Drug Bioavailabil ity IO/88

FDA Perspective
Universidad International Santiago,

Topical Drug Delivery - Regulatory Issues Science Center App’ lied Pharmaceutical East Brunswick, New Jersey Invited Speaker and Gxmmi ttee Member Drug Regulation of Nove7 Drug De7ivery Systems Third International Conference on Drug Absorption Rate Controt in Drug Therapy Edinburgh, Scotland *Q Presented invited papers at the 13th, llth, 19th, 2&t, 23rd, 24th, ZSth, 26th and 31st Annual International Industria’ l Pharmacy Symposia, and was a Reactor Pane7 Member for 22nd Symposium. Chaired panels for 24th-31st International Symposia International Industrial Pharmacy Conference Retinoids and Clucocorticoid Shah. V. P., Skelly, I, P. Cannes, France Biopharmaceutic Electronic Drug Information Association, Toronto, Canada Computer Assisted NDA Review PMA/FDA Meeting Eal timore, Maryland Dermatology Project.

10,'88

9/88

1974-1993

8/88 NDA’ s 24th Annual Meeting 7/88

6/88

23 In Vitro Release Profi'le of C'lonidine Scopolamine Transderma? Patches. AAPS, Eastern Regional Meeting Atlantic City, New Jersey and 6/88

Therapeutic and Biopharmaceutics Evaluation of Ora Extended Re'lease Forms. Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik Techno7ogy Seminar Wurzburg, West Germany In Vitro Methods for Topical Drug Products Shah. V. P., and Skel7y, 1. P. 5th Annual Symposium of Skin Pharmaco'logy Society Paris, France 1988 Seminar Series Topical Disso7ution Characterization for Controlled Release Forms King of Prussia, Pennsylvania Ora
Symposium

6/88

S/88

4/88

Controlled Re'leased Dosage Forms: on Eva7uation of Contro77ed Released Dosage Forms Woodcliff Lake, New Jersey of

3/88

The Use of Topographica Ana7ysis in Control Controlled Release Drugs Piational Organization for Drug Control Cairo, Egypt

10/87

In Vitro Disso'lution Testing and In Vivo Correlations National Organization for Drug Contro7 and Research Cairo, Egypt In Vivo-In Vitro Relationship Schoo'l of Pharmacy Cairo University Cairo, Egypt Drug Regulation and llraportance of In Vitro University of Alexandria: A'Jexandria, Egypt Dissolution

10/87

lo/87

IO/87

Pharmacokinetic Aspects of Sustained Release Products With Special Reference to FDA Requirements Neu Ulm Conference; Neu Ulm, West Germany Pharmacokinetics in Drug Development First Annual Symposium of the Eastern Regional Group American Association of Pharmaceutical Scientists Atlantic City, New 3ersey

9/87

9/87

24
Sponsor and Moderator . Anti-Cancer and Ophthalmic Drugs Workshop. American Association of Pharmaceutical Scientists. Boston, flassachusetts Panelist. Targeted Drug Del ivery Systems . American Association of Pharmaceutical Scientists Boston, Massachusetts 2nd Meeting and Exposition; for Developing A Dissolution for Enteric Coated Erythromycin Tablets. American Association of Pharmaceutics 1 Science Boston, Massachusetts

6/87

6/87
Test

Some Considerations

6/87 ISDU 6/87

Study of Dissolution
CR Tab? e ts and Capsule Bos ton r Massachusetts

Media for Testing Forms AAPS

Commercial

Inf7uence of pH on the Dissolution Profile of Marketed Diazepam Products AAPS Boston, Rassachuset ts
Higher

6/87 Necessary
for

Imediate
Boston,

Agitation for Disso7ution Release Products AAPS flassachuset ts

Standard

6/%7
Controlled Scientists

Effect of Food on Bioavailability of Release Theophylline Products American Association of Pharmaceutical Washington, D. C. Pharmacokinetics in the E7derly Reactor, Geriatric Drug Update National Institute of fiealth Bethesda , Maryland Bioavailability/Bioequivalence

6/87

- 1987. S/87
-Pharmaceutica’ l Coating

and Control 7ed Release
Arnold Saddle and Marie Schwartz Brook, New Jersey

Techrtologies
Col7ege of

Symposium.
Pharmacy

S/87
Approval. Symposium.

Bio-Pharmaceutical Requirements for Pre-Market Global Pharmaceutical Development & Registration Twenty-Third Annua7 Meeting of the Drug Information Association. San Francisco, California Control led Release Guidelines Biopharmaceutics Seminar Center for Drugs Rockvil le, Md. Evaluation of Controlled Release Dosage Forms. DraJ Controlled Release Dosage Forms Symposium Modcliff Lake, New Jersey

S/87

4/87

3/87

25
Food Effects in New Drug Development. Division of Biopharmaceutics and Pharmaceutical Manufacturers Association, Washington, D. C. Regulatory Considerations Testing in USA. Arbeitsgemeinschaft Fur Wurzburg, West Germany Federation Internationale Working Group on Use of for Dissolution Testing Frankfurt, West Germany in Rioavailability Pharmazeutische Verfahrenstechnik Z/87 Pharmaceutique the Flow-Through System of Controlled Release Forms. Z/87 and/or Predictability Vivo Studies. l/87 8th, 9th, of the 1980, 1981, 1982 1986 and 1990 Scientists 12/86

Workshop 3/87

The Current Status of the Correlation of In Vitro Studies as Compared to In FDA/Industry Workshop (w/S&do& East Hanover, New Jersey ** Presented Invited papers at the 7th, 13th and 17th International Meetings Control led Release Society

Drug Bioavailabil i ty and Bioequivalence #A Perspective III Latino-American Meeting of Pharmaceutical Montevideo, Uruguay Pharmacokinetic/Regulatory Drug Delivery Systems 1986 Neu Ulm Conference New Urn, West Germany Aspects of

Transdermal Delivery Rate of H/86 Systems 12/86

on Transdetmal Dissolution

Effect of pH on the In Vitro Diazepam Tablets USP AAPS. Washington, D. C. Development of a Dissolution Coqjugated Estrogens Tablets. AAPS. Washington, D. C. Principles and Practices Percutaneous Penetration Traqsdennal Workshop --

Test

for _

USP 11/86

of In Vitro Studies AAPS and RIA; ifydrocortisone

Washington, Acetate

D. C.

U/86

Bioavailability of Topical In Vivo-In Vitro Correlations AAPS: Washington, D. C. Standardization of Dissolution AAPS. Washington, D. C.

Specifications In Vitro 11/86 of Whole Tablets vs. Halved 11/86

A Novel Approach for Determining Dry aelease Rate for Creams AA Pii! :. Washington, D. C. Analysis of In Vitro Dissolution Control led Release Theophyline D. C. AAPS - Washington,

26 Comparative In Vitro Release Profi'les of Marketed Nitrog7ycerin Patches by Different Disso7ution Methods American Association of Pharmaceutical Scientists
Washington, D. C.

11/86

An Anima? Mode? for Bioavai7abi7ity Study on Contro7?ed-Re7ease Formufations Under Influence of Food American Association of Pharmaceutica'i Scientists Washington, D. C. Evaluation of Disso?ution Methodo'logy for Ibuprofen American Association of Pharmaceutica7 Scientists Washington, D. C. FDA Biophamtaceutics Japan Pharmaceutical Rockvi??e, Maryland
Program

H/S6

Tab‘ lets 11/86

Manufacturers

Association
1 O/86

Eva7uation of Contro7led Re7ease Dosage Forms Eastern Regulatory Pharmaceutics? Discussion Group of the AAPs and Hudson Val7ey AAPS Group Montvale, New Jersey

9/86

Topographical Dissolution Characterization of Controlled Release Dosaae Forms and Their Relationshin to In Vivo Drug Absorption Thirteenth Iiternationa7 Symposium on Controlled Re7ease of Bioactive Materials S/86 Norfo‘ lk, Virginia USA Regu7atory Considerations in Bioavai7ability Testing Fifth International Symposium on Bioavai7ability l Third World Conference on C?inica’ Pharmaco?ogy and Therapeutics Cothenburg, Sweden Pana7ist: Discussion Population Pharmacokinetics, Application to Drug Devetopment and lJti?ization. University of Pittsburgh Pittsburgh, Pennsylvania InterphexDisso'lution Tests for Ora? Extended Re'iease Products and Drug Re?ease Tests for Transdermals Interphex 1986 New York, N. Y.
Novel Drug De?ivery Systems Association of Official Ana7ytica7 Seattle, Washington

7/86

S/86

4,‘ 86

chemists

4/86

Biopharraaceutics in Drug Regu'lations University of Saskatchewan Collage of Pharmacy Saskatoon, Saskatchewan, Canada International Symposium on Drug Analysis: Current Cha77enges. Sate71 ite Symposium 45th International Congress. Sponsored by Health and We7fare Canada Ottawa, Ontario, Canada

11/85

H/85

27
Biophafmaceutics in NDA/ANDA submission. Drug In format ion Association Workshop Hi7 ton Head, South Caro7ina Preparation of High Purity Reference Standards of Nitrog7ycerin Dinitration Products and the Deve’ lopment of Comp’ leinentary HPLC-CC Ana’ lyses Academy of Pharmaceutica’ l Sciences Nationa Meeting Minneapo7 is, Minnesota The Ana7ysis of Prednisolone Acetate and Re7ated Corticoids in Swine P7asma by Reversed Phase HPLC. Academy of Pharmaceutical Sciences Nationa Meeting Minneapolis, Minnesota The Effects Academy of of Food on Absorption Phamaceutica7 Sciences of Contro77ed Re7ease

11/85

IO/85

Minneapolis,
In Vitro

Minnesota

lo/85

Methodo’ logy: Re7ation to In Vivo Chemists for Drug Eva’ luation and Research Rockvi77e, Mary’ land

Seminar,

Center

lo/85

Disso’ lu t ion of Transderma Federation International PIon trea 7, Canada Forty-fifth Sciences Mowtrea?,

7 Patches Phamaceutique

6/85 Congress of Pharmaceutica7
Pharmaceutique

Internationat

of Federation Internationa7e Quebec, Canada

9/85
Conference

Second Contro7 Re’ lease Specia7 Pittsburgh, Pennsy7vania Phamaceutica’ l Manufacturers Drug Metabo’ lism Subsection Bethesda, Maryland

ty Chemica7

7/85
Workshop.

Association Workshop

Biopharwaceutic Considerations in Design and Evaluation of Novel Drug Detivery Systems. University of New York at Bufffo (SUN0 Buffa70, New York Biophamaceutic Considerations Eva7ation of Nove7 Drug Delivery University of Buffa7o; Buffa70, Dossier D’ Autorisationde Assoc. Pour Le Deve7op. Montpe7 7 ier, France in Designing Systents New York and

4/85

Mise Sur Le Marche De La Pharmacokinetique 3/85
Bioequiva7ence

Vitro Technique for Assuring for Contro77ed Re7ease Dosage Forms Assoc. of C7 in. Pharwaco7ogy San Antonio, Texas
Biopharmaceutic Considerations Drug Infomation Association Bethesda, Mary7and

Nove7 In

3/85
Drug Research

in Geriatric

3/85

Novel Drug Delivery Systems Twenty-fourth Internationa7 Austin, Texas of KINPAK - Evaluation Pharmacokine tic Data. Rockville, Maryland

Industrial

Pharmacy System for

Conference z/iv Organizing U/84

New Computer

FDA Guide1 ines for Controlled Ske7lv. J. P. and Viswanathan, R-EXPD Industriaf Pharmacy New York, New York Pane7 Member -- Toxicokinetics Pharmaceutical Manufacturers Drug iYetabo7ism Subsection Philadelphia, Pennsylvania Pharmacokinetic Differences Workshop on Pharmacokinetics American Sot. for C7inica7 Rockvi7le, Mary7and

Release C. T.

Dosage

Forms N/84

Association 9/84 in the Elder7y. in the Elder7y Pharmaco’ logy and

Therapeutics 9/84

Role of Metabo’ fite: FDA Point of View Viswanathan. C. T. , and Ske7 ly, 3. P. Academy of Pharmaceutical Sciences Phi Tade7phia , Pennsylvania Transdermal Dosage Forms Academy of Pharnraceutical Somerset. New Jersey - Regulatory Sciences Point of View

9/84

9/84 on 8/84

The &pact of Biopharmaceutic Research The ffegu7atory Process American Chemical Society Symposium Philadelphia, Pennsylvania OTC Combination Pharntacokinetics Bad Lauderburg, Pharmacokinetics Pharmacokinetics Bad Lauderburg, Control led University Manchester, Products and Biophamnaceutics, Germany

Advanced

Course 6/84

and Control’ led Release Drugs and Biopharmaceutics, Advanced Germany

Course, 6/84

Re’ lease Drugs of Manchester Eng7and
Subjects

6/84

Phannacokinetic Studies in E7derly and Other Specia7 Populations . Controlled Release Dosage Forms Association Philadelphia, of Official Analytical Pennsy7vania

5/84 Chemists 5/84

29
Pharmaceutics Pharmacodynamic Drug Disposition of the 1984 American Pharmaceutica7 Association Academy of Pharwaceu t ica 7 Sciences Plidwest Regiona Meeting Section

Basic

Chicago,

I’ linois l’
in Drug Studies Industria7

4/84

Regu7atory Perspectives Pharmacokinetic Considerations Twenty-third Annua7 Internationa7 Pharmacy Conference Austin, Texas

2/84

Biophamaceutic Considerations in Designing and Eva’ luating Nove7 Drug De7ivery Systems Nationa Meeting of the American Thirty-fifth Pharmaceutical Association Academy of Phamaceutica‘ l Sciences (short course) Miami Beach, Florida Guide7 ines Considerations in Conducting Pharmacokinetic Studies Symposiutn on Role of C’ tinical Pharmacokinetics in Drug Deve’ iopment and Therapy Miami, Florida FDA Perspective Proposed VSP Po7 icy on Modified Re’ lease Academy of Pharmaceutical Science Miami, Florida Controlled Schoo7 of Release Drug Products Pharmacy, Rutgers University hsage Forms.

U/83

U/83

U/83

Piscataway,

New Jersey

U/83

Issues of Bioavailability and Bioequivalence. II Reunion Latino Americana de Ciencias Fatmaceuticas Colegio De f&i&co-Farwaceuticos De Chi7e Santiago, Chile Correlation and/or Predictability Studies to In Vivo Studies Industry - n[lA Workshop East Hanover, New Jersey of In Vitro

1 l/83

10/83 led

Biopharutaceutic Issues Related to Contro7 Re ‘ lease Drug Products . Purdue University Management Conference West Lafayette, Indiana Regulatory Considerations for Control Drug Products. Twenty-fifth Annual National Industrial Research Conference University of Wisconsin Lake Del ton, Wisconsin

9/83

7ed Release Pharmaceutica7

6/83

30
Cl inica7 Pharmacokinetics Third Workshop on C7inica7 Pharmacokinetics Drug Retabo7ism Managers Group Washington, D. C. Industria7 Issues: Reactor Panalist Twenty-second Annual Internationa’ l Pharmacy Symposium Austin, Texas Industrial 2/83

3/83

Pane7 ist: “ What It lakes ‘ to Make a Successfu7 Control 7ed Re’ lease Pharmaceutical Product”. Ninth Internationa7 Symposium on Contro’ lled Release of Bioactive Materia’ l Fort Lauderda’ le, Rorida Deve7opment of Biopharmaceutic Twenty-first Annual Internationa’ l Pharnracy Conference Lakeway Inn, Austin, Texas Naster Fi7es Industria7

7/82

2/82 tics l/82

Drug Bioavailabil ity. Second Workshop on C7 inical Pharmacokine Drug Retabo7 ism Managers Group Washington, D. C. Sustained Release Technology Forum: Regulatory Agency’ s Viewpoint . Entomo7ogica7 Society of America Meeting San Diego, Ca7ifornia

ll/Sl of Release 7/81 Clucocorticoid

Guide7ines for Eva’ Juating the Bioavai7abi7ity Gontro77ed Release Dosage Forms. Eighth Internationa7 Smposium on Contro77ed of Bioactive Plateriat Fort Lauderdale, Florida Isotope Labe7ing and Mass Spectroscopy Bioavai7abi7ity Studies. Academy of Phatmaceutica7 Sciences Midwest Regiona Meeting Chicago, I7 7 inois Preclearance of Generics “An FD4 Perspective. ” Austin, Texas - Yes or No? in

s/81

2/81 Workshop l/81 of Drug on the Products 8/80

Drug Metabo7ism Managers Group in C7 incia7 Pharmacokinetics Washington, D. C. The FDA and the Bioequivalence ne 2nd Congress of Chemistry North American Continent Las Vegas, Nevada

31
The FDA and Controlled Re’ lease Delivery Systems Biopharmaceutics Perspective Seventh International Symposium Controlled Release

Society t/80

fort

Lauderda7e,

florida
Health Sciences: Interactions. of Pledicine

FDA Representative Revson Conference of Frontiers in the ljnpl ications of Environmenta7/Cenetic Nationa Academy of Sciences, Institute Washington, D. C.

7/80

Disso7ution as a Predictor of Bioavai7abiZity Research Society of America/Signs Xi Rockvi77e, Mary’ land Risso7ution Proficiency Testing Seventeenth Annual Internationa’ l Pharmacy Conference Austin, Texas FDA Po7icy in Regard to Disso’ lution Pernarowski Memorial Seminar Academy of Pharmaceu t ica 7 Sciences Bontrea7, Canada Ro7e of Dissolution Drug Bioequiva’ lence Mid-West Regional Chicago, I71 imis in Assessing Academy of Industria’ l

3/79

r/79
Techno7ogy 5/78 and Predicting Sciences, 4/78 Technology S/78

Pharmaceutical

FDA Policy in Regard to Disso’ lution Pernarowski UmorikG Seminar Academy of Pharmacoutica’ l Sciences Mcmtrea7, Canada

Bioequiva’ lence and Issues of Drug Interchangeabi’ lity 6oards and Co7leges of Pharmacy, Region II ,. Si7ver Spring, -Mary‘ land I’ lementation mp’ of the Bioavailabi7ity Bioeguiva7ence Regu’ 7cltions Management Science Conference for Purdue University West Lafayette, Indiana Maximum AI7owable Cost HEW Portal Bui’ lding Washingtvn, D. C. Advisory and the Pharmaceutical Industry

IO/77

9/77 -ittee 9/77

Pharmacokinetic and Eletabo’ lic Studies of Chlomzotocin in Mice @atre. R. Schein, P., Ske77y, J., Waravdekar, American Association of Cancer Research Denver, Co7orado

V. r/77

32
Bioavai7abi7ity, Bioequivalence Bureau of Drugs Seminar Rockvi77e, Maryland and Related Xssues 3/77 Out Vitro

Proficiency Testing: Guide?ines for Carrying Disso?ution Tests Which Are CIassified as In Bioequivalence Requirements Pbarmaceutica7 Manufacturers Association Shorettam Americana Hot@7 Washington, 77. C. Bioavai7abi7ity Update American Academy of Pediatrics, Washington, 5. C. FDA Representative Parentera Amino Acids American Academy of Pediatrics Bethesda, Nary7and Bioavai7abUity and Bioequivalence American Co7 7ege of C7inical Pharmaco7ogy Phi’ ladelphia, Pennsy’ lvania Problems Encountered in of Drug Bioavai7ability Bureau of Drugs Chemists Rockvi7 7e, Marytand the Determination Committee

3/77

on Drugs 3/77

S/76

4/76

Seminar 3/76 Association Medical 11/75 ity Issues in Pediatrics Committee on Drugs 1 o/75 Regu’ lations Discussion Group s/75 Requirements 10/74

RIA Pane7ist Pharmaceutical Manufacturers Section, Interim fleeting Washington, 5. C,

- Bioavai7abil FDA Representative American Academy of Pediatrics, Washington, D. C.

FDA and Bioavai7abi7ity/Bioequiva7ency San Francisco Bay Area Pharmaceutical San Francisco, Ca7ifornia Pharmaceutica’ l Update-FDA’ s Bioavai7abi7ity American Medica Writers Asssociation Los Ange7es, Ca7ifornia

FDA Bioavai7abi7ity Guide7ines and Po7icies West Virginia 5. Pharmacy Institute Eforgantown, West Virginia Guide7ines to be Emp7oyed for Antibiotic Bioavai7abi7ity Studies Conference on Antibiotic FDA - Industria7 Ruckvi7 7e, Mary’ land

6,‘ 74

Bioavai7abi7ity S/74

33
Drug Bioavaiiabi7ity, Time Re7ease, 1974 FDA fie’ ld Drug Workshop Philadelphia, Pennsylvania New FDA Digoxin Regu7ations Association of Food and Drug Lancaster, Pennsy’ lvania Officia’ ls In Vitro Testing

s/74

5/74

Consumer Issues Invo7ved in the Generic Versus Brand “ Federa? Activities ‘ and Initiatives”. Name Drug Debate: (Joint Session Eastern Council of State Governments and Sou them Regiona 7 Conferences) . At’ lanta, Georgia BioavaiJabi7ity Policies and Guidelines Thirteenth Annua7 Internationa7 Industria7 Pharmacy Conference Austin, Texas Bioavailabi? ity and the FDA 57th Annual Conference of the Centra7 Association of Food and Drug Officia7s cO77ege Park, Mary’ land FDA Representative Nationa Workshop Research Triang7e, At7antic States

4/74

2/74

s/73

on Digoxin Bioavai7abi7ity North Car07 ina in Induced - American Atherosclerosis Chemical Society

3/73

Co77agen and E7astin Metabo7ism Midsle Atlantic Regiona Meeting Ba7 timore, Mary’ land Bioequiva7ence of Pheny’ ibutazone Division of Fletabo‘ lic Endocrine Bureau of Medicine Rockvi 7 7 e I Mary7and

2/71 Drug Product

9/70

INTERNA TIDNAL MEETINGS: Sca7e-Up Second Assiut Assiut,

Immediate

Changes & Post Approva7 Refease & Modified Release Dosage Pharmaceutica7 Sciences Conference University Egypt Symposium

Forms

3/2000 3/2000

MDS Pharmacokinetics Lyon, France

hi ,i

34

In-Viva/In V itro Correlations S e c o n d P h a r m a c e u tica'l S c i e n c e s C o n fe r e n c e Assiut University Assiut E g ,vpt M o d e r a tor D r u g De7ivery P h o e n i x In te r n a tio n a 7 M o n trea7, C a n a d a

3 /2 0 & J

Symposium

6 /9 9
4 /9 7

Q u o V a d i s M e d i c a m e n tu m Bobenheim, Germany

D r u g A p p r o v a 'l! F u tu r e A s p e c ts o f F D A

R a p p o r teur, B iolnternational '9 4 B i o e q u i v a 7 e n c e : Q u a 'iity C o n tro7 a n d T h e r a p e u tic S u r r o g a te B ioInternationa7 '9 4 Munich, Germany P o te n tia 'l E ffects o f H e a r th c a r e R e fo r m o n th e P h a r m a c e u tical In d u s try P h o e n i x In te r n a tio n a l Life Sciences: Fifth A n n u a l S y m p o s i u m M o n trea'l, Q u e b e c , C a n a d a E v a 'lu a tio n o f R e g u 'la tory G u idelines B a s e d o n C a s e Histories S e c o n d In te r n a tio n a 7 C o n fe r e n c e o n C o n trol7ed R e 'le a s e D o s a g e F o r m s Zurich, S w i tzerland In V itro/In V ivo C o r r e 7 a tio n s in B i o p h a r m a c e u tics: S c i e n tific & R e g u 'la tory Im p 7 i c a tio n s 5 th E u r o p e a n C o n g r e s s B i o p h a n n a c e u tics a n d P h a r m a c o k i n e tics B russe'ls, B e 'lg i u m H o w to D e fin e a P a n e 7 o f V o l u n teers 3rd RegipharmSymposium F r o m H u m a nM icrosomes to M u 7 tin a tio n a 7 Registration Fi7es: A n In te g r a te d A p p r o a c h to H u m a n P h a r m a c o k i n e tics D e v e 7 o p m e n t B russe7s, B e 'lg i u m R e g u 7 a tory A s s e s s m e n t o f C o n t r o 7 7 e d D r u g Delivery P h a r m a c y W o rld C o n g r e s s '9 2 F e d e r a tio n In te r n a tio n a 'ie P h a r m a c e u tiq u e , Ip h a r m a x a n d N a tio n a C o n g r e s s o f F r e n c h P h a r m a c i s ts Lyon, France

6 /9 4

s/94

3 /9 4

4 /9 3

m /9 2

1992

35
‘ 92 Conference Commit tee Member, BioIn terna t iona? Bioavai7ability/Bioequiva7ence % Pharmacokinectic Studies Panel Co-Chair and Pane’ list on ‘ Bioequiva7ence of High7y Variab7e Drugs II’ Bad Horn&erg/Frank fort, Germany Plenary Session Moderator & Pana7ist International Dpen Conference USP, HP5, & FDA Toronto, Canada Case Histories: First Internationa7 Conference Ora 7 Contro7 7ed Dosage Forms Berlin, Germany Ana7ytica7 Methods Va7idation for Bioavai7abi7ity and Bioequiva’ lence Studies Second Symposium on Drug Bioavai7ability Santiago, Chi’ le Co-Chairman: Bioavai7abi7ity and Bioequiva7ence Pharmacy Wor7d Congress - FIP; Wash. D. C.

1992

1992

1992

2991 and Wor’ Standards ld 1991

Regu7atory Requirements for Qua7 ity Contro’ l and Assessment of Bioavai7abUity and Bioequiva?ence Pharmacy Wor7d Congress - FIP Washington, D. C. Ana’ lytica’ l Austra’ lian Ade’ laide, Symposium Austra’ lian Ade7aide, Methods Va7idation and Stabijrity Pharmaceutical Science Association Austra’ lia Summation and Commentary Pharmaceutica7 Science Association Austra’ lia Studies

1991

1991

1991

The Research Program Center for Drug fva’ luation & Research Therapeutic Goods Administration Canberra, Austra’ lia The United States Drug Approva7 Process “Sea Change or Temporary Turbu’ lance” Therapeutic Goods Administration Aus tra 7 ia Canberra, Drug Registration Update and Trends Brusse7s. Be’ lgium in Europe: for the Future

1991

1991

1990

36
European Commission Ad Hoc Coitnnittee on the Definition of Bioavai7abi7ity: Federation Internationa7e Pharmaceutique Sate7 7ite Conference Munich, Germany BioInternationa7 ‘ 89 Eva’ luation of Bioavailabi7ity Ontario, Canada
:?5

1989

Data 1989 Seminars 11/89

Nationa Institute of ffygenic Sciences Eva7uation of Dosage Form Design Tokyo, Osaka and Kyoto, Japan Internationa7 Symposium Universidad De Chi7e Santiago, Chi7e on Drug

Bioavai7abiiity 10/89

Invited Speaker and Committee Member Drug Regu’ iation on Nove7 Drug De7ivery Systems Second In terna t iona 7 Con ference on Drug Absorption Rate Contro7 in Drug Therapy Edinburgh, Scot’ land Retinoids Project Cannes, and Dermatology of G7ucocorticoids France Information Association

9/88

S/88

Twenty-Fourth Annua7 Pfeeting, Drug Biopharmaceutics E‘ lectronic NDA’ s Toron to, Canada

7/88 Seminar 6/88

Intern’ 7 Association for Pharmaceutica’ l Technoiogy Therapeutic and Biopharmaceutic Evaiuation of Ura7 Extended Re7ease Forms Wurzburg, West Germany In Vitro Rethods for 5th Annuai Symposium Paris, France Topical of Skin Drug Products Pharmacology Society

f/88 of Sustained Re7ease to FDA Requirements Products 9/87 and In Vivo Corre7ations 9/87

Pharmacokinetic Aspects with Specia7 Reference New Urn, West Germany

World Hea7th Organization In Vitro Disso7ution Testing Cairo, Egypt ** Mu7tip7e presentations

37
Federation Internationa7e Pharmaceutique Working Group on Use of F?ow-Through System for Disso7ution Testing of Contro77ed Re7ease Frankfurt, West Germany USA Regulatory Considerations Internationa7 Association for Wurzburg, West Germany in Bioavai7abiSity fharmaceuticail

Forms Z/87 Testing Techno7ogy Z/87 1980, 1981, and 1986 1982

Presented Invited papers at the 7th, %th, 9th, and 13th Internationa’ l Meetings of the Contro77ed Re7ease Society Fifth International Symposium on Bioavailability Third Wor7d Conference on C7inica7 Pharmaco7ogy and Therapeutics Go thenburg, Sweden Drug Bioavai7abi7ity Third Latino American Montevideo , Uruguay Pharmacokinetic/Regu?atory 1986 Meu V7m Conference Mew Ulm, West Germany Dossier D’ Autorisationde Assoc. Pour Le deve7op. Montpe? 7 ier, France Biopharmaceutics in Co77ege of Pharmacy, 45th Internationa7 Montrea 7, Quebec, 5ioequiva7ence, FDA Perspective Meeting of Pharmaceutics? Science

Ju7y/Aug.,l986

11/86 Aspects of on Transderma7 Transderma7 Drug De7ivery De7ivery Systems Systems U/86 Mise Sur Le Marche De La Pharmacokinetique 3/85 Saskatchewan Sciences, PIP 9/85 Patches 9/85 3/85

Drug Regulation University of of

Congress Canada

Pharmaceutica7

Disso’ iution of Transdema7 Pfontrea 7, Canada

Symposium on Drug Ana’ tysisr Current Cha77enges. Sate77ite Symposium of the 4Sth Internationa’ l Congress Sponsored by Hea7th and We7fare Canada Ottawa, Ontario, Canada Seminar Ottawa, to Drug Ontario, Directorate Canada -Staff, HP5 Hea7th and Welfare

9/85 9/85

Facu7 ty Pknrber Pharmacokinetics Bad Lauderburg,

Advanced fharmacokinetics & /Biopharmaceutics, Advanced Germany

Course 6/‘ 84

38
Contro7led University Manchester, Re7ease Drugs of Manchester England

6,‘ 84

Issues of Bioavai7ability and Hoequivalence II Reunion Latin0 Americana de Ciencias Farmaceuticas Co’ legio De Quimico-Farmaceuticos De Chile Santiago, Chi7e Invited Speaker (persona7 invitation) Second Interna t iona Conference on Drug Absorp t ion Rate Contro7 in Drug Therapy Edinburgh, Scot’ land (Unab7e to go because of fack of Invited Speaker and Invited Workshop Pana Federation Internationafe Pharmaceutique Montreaux, Switzerland Modest Pernarouski Memoria7 Seminar International Meeting of the Academy Montreal, Canada of ist

11/83

funds)

9/83

9/83 Sciences 10/78

Pharmaceutica7

PUBLICA7IONS: Van Buskirk, Zenie, F.,G., Layloff, T., Ske’ lly, J-P. ; Paper’ less Laboratories They’ re Inevitab’ Jei The Paper?ess Laboratory - Fina77y A Reality; American Pharmaceutical Review, Page 100-106. December, 2002. Ske77y, J. P. : Pharmaceutical Sca7e-Up and Post Approva’ l Techno‘ logy. Marce’ Dekker, l Changes (SUPAC). N. Y. 2002 Encyclopedia of -

Jiang, M., Qureshi, 5. A., Midha, K., & Ske77y, J. Percutaneious Absorption of an Acyc’ lover Product. Human Skin. Journa7 of Pharm. & Pharm. Sci. Jan., Endrenyi, Attractive

P. I In Vitro Eva7uation of Using Intact and Taped-Stripped 99 Bioequiva7ence: 1321-1325: 1998

L., Amidon, G. L., Midha, K., & Ske77y, 3. P.: Individual in Princip7e, Difficult in Practice. Pharm. Res. 15(9)

Ske77y, J. P. : Drug Approval - Future Aspects of FDA in Proceedings “Quo Vadis Medicamentum” Institute Fur Klenische Pharmako’ logic In Methods & Findings in Expermenta7 C7 inca7 Pharmacology. 20(6> : 1998 Crison, 3., Shah, V. P., Ske’ lfy, J. P. , Amidon, G. L. : Drug Dissolution Development of a Convective Diffusion Mode7 and Comparison S07utions: Equilibrium Model with App7ication to Surfactant-Faci7itated Disso7ution Carbamazepine. J. Pharm. Sci. pages 1005-1011; Sept.; 85(g), 1996. into Mice7lar to the Fi7m of

39
Ske77y, 3. P., Van Buskirk, G. A., Arbit, H. M., Antidon, G. L., Augsburger, L., Barr, w. H., Berge, S., Cfevenger, 3., Dighe, S., Fawzi, M., Fox, D., Gonzalez, M, A., S., Robinson, Gray, A. , Porter, 3., Save770, ff. R., Schwartz, P. , Schwartz, 3. B., & Shah, V. P. : Sca’ le-Up of Ora Extended-Re7ease Dosage Forms. Pharmaceutica‘ l Techno7ogy Pages 46-54, May 1995. Shah, V. P. , Noory, A. , Noory, C. , McCu77ough, B. , CTarke, S., Everett, R. , Noviosky, H . , Srinivason, B. N., Fortman, D., & Ske77y, 3. P. : In Vftro Disso7ution of Sparing7y Water-Solub’ le Drug Dosage Forms. Intl. Jr. of Pharm. f25:99-106: 1995 Ske77y, J. P., Van Buskirk, G. A., M. B., Gonza’ Dighe, S., Fawzi, lez, F True’ love, 3. : Workshop Report: Eu;. Pharm. Tech. 58: 74: 1995 Save7?o, 0. R., Amidon, G. L., Arbit, H, M., M. A., Ma7ick, A. W., Shah, V. P. I Shangraw, R. Sca7e-Up of Immediate Re’ lease Ora Dose Forms. M., K. ,

Van Buskirk, G. A., Shah, V. P., Adair, 0. I Arbit, fi. PI., Dighe, S. V., Fawsi, Fe7dman, T. , Rynn, G. L . , Gonza7er. M. A. , Gray, V. A. , Guy, R. H. , Herd, A. Hem, S. L., Hoiberg, C., Jerussi, R. I Kap’ lan, A. S., Lesko, L. 3., Ma7inowski, Me? tzer, N. M., Nedich, R. L. , Pearce, 0. M. , Peck, G., R&man, A., Save770, Schwartz, -7. B., Schwartz, P, , Ske77y. -7. P., VanderTaan, R. K., Wang, 3. C. 0, R., & Zatz, 3. L.: Workshop III Report: Scale-Up of Weiner, N., Winke7, Pharm. Res. 11:1216-1220: 1994 and Semis07 id Disperse Systems. Ske77y, J. P. : Wor’ Wide Problems: ld Pharmaceutica7 Techno’ logy Symosium; de Santa - France 1994 Ske77y, Scientific 121-129: J. P., & Shiu, & Regulatory 1993 Proceedings of the Hacettepe University, 7th International Ankara, Turkey.

H. 3.)
0. ,

T.,
Liquid

Editions

G. F. : In Vitro/In Vivo Corre7ations Eur. Jr. Drug Metab Implications:

in Biopharmaceutics: & Pharmocokinetic

18(l):

Intearation of Pharmacokinetics. Pharmacodvnamics. Drua De’ liverv. Editors: Yacobi, A., Skef ly, J. P’ lenutn Press N. Y. & London: 1993 Skelly, Important 3. M. A.: P., & Gonza7ez, Eur. Jr. Contribution.

P.,

and Toxicokinetics in Rationa Shah, V., & Benet, L. Z. : - Simp7e 1993 Too7,

FDA Update: Disso7ution Testing Pharm. & Biopharm. : 39(5)222-223:

Considerations in Deve7oping Shah, V. P. f & Ske77y, 3. P. , : Practical Control (In-Vitro Re’ lease Procedure for Dermato’ logica7 Products. In: Editors: Shah, V., Bioavai7abilitv. Bioecruiva’ lence and Penetration. I. Plenum Press, N. Y. % London. 1993 T. M., Dighe, S. V., Skel7y, J. Shah, V. P. , Ludden, Biopharmaceutic Considerations for Transderma7 Drug Drun Bioavai7abi7itv. Bioeauiva7ence % Penetration. H. I. P7enum Press, N. Y. & London. 1993 3. P. : Ana7ytical Shah, V. P., & Ske77y, Bioequivalence, & Pharmocokinetic Studies. Snmwsia Internaciona7 I. Ed.: Arancibia,

a Quality Topica Drug & Maibach, H.

P. I 8 Wi’ lliams, R. L. : De7ivery Systems. In: Topica Editors: Shah, V. P. & Maibach,

Methods VaIidations; Bioavi7abi7ity, In: Biodisoonibi7idad de Medicamentos: Agui’ les & Pezoa, Regina. Page 145 1993

40
G., Arbit, H.m., Amidon, G. i., Augsburger, L., Barr, W.H., Ske77y, J. P., Van Buskirk, Bcrge, 5. , C7evenger, 3. , Dighe, 5. , Fawzi , M. , Fox, D. , Gonza7ez. M. , Gray, A, , Porter, S., Robinson, 3.. Saveffo, D., Schwartz, P., Schwartz, J.B., Shah, V., : Sca'Je-Up of Ora Extended Release Dosage Forms. Pharm. Res. lU:1800-1805:1993. Wang, 1. T., Shiu, G. K., Chen, T. O., of Humidity and Temperature on In Vitro Pharm. Sci. 83:1002-1005: 1993 Viswanathan, Disso7ution C. T., & Ske77y,

of Carbamarepine

3. P.: Tab’ lets.

Effects J.

Ske77y, 3. P. , Van Buskirk, G., Save’ llo, D. R., Amidon, G. L., Arbit, H. PI., Dighe, M. A., Ma7ick, A. W., Ma7inowski, H, , Nedich, R., Pearce, 5 Fawzi, M. B. , Gonza7ez, D:'N.. Peck, G. E. I Schwartz, 3. B., Shah, V-P., Shangraw, R. F., & True7ove, J7. : Sca’ le-Up of Immediate Release &a7 So7id Dosage Forms. Pharm. Res. 10:313-3X: 1993 Eur. 3. Pharm. & Biopharm. 39:40-43: 1993 Peck, C. , Barr, W. H., Benet, L. Z., Co77ins, J., Desjardins, R., Furst, D., Harter, 3. c., Levy, G., Ludden, T., Rodman, 1., Sananthanan, L. r Schentag, I,, Shah, V., Sheiner, L. B., Ske77y, 3. P., Stanski, D. R., Temp’ le, R., Viswanathan, C. T., Weissinger, J., & Yacobi, A, : Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, & Toxicokinetics in Rationa Drug Deve’ lopment. Pharm. Res. 9(6):826-833: 1992 Journa7 of C7inica7 Pharmacology and Therapeutics: 51(4):465-473: 1992 Int’ 7 Jr. of Pharm. 82:9-19: 1992 Shah, V. P., Ske77y, 3. P., Contro7 7ed Re7ease Products: 16(5) : 35-38: 1992 Barr, W. H., Pre7 iminary Amidon, G., Ma7inowski, H. : Sca’ le-Up of Pharmaceutics? Techno7ogy Considerations. Higher 1. Phatm.

Shah, V. P., Buborg, M., Noory, A., Dighe, S., Ske77y, J7. P. : Inf7uence of Raes of Agitation on Re7ease Profi7es of Immediate-Re7ease Drug Products. Sci. 81 :~OO-503: 1992 Shah, V. P., and In Vitro 59: 1992 E7kins 1. I & Ske77y, 3. P. : Re7ationship Re7ease Rate for Betamethasone Va’ lerate

between In Vivo Skin B’ lanching 3. Pharm. Sci. 81:55Creams. A., 5.: Lay’ loff, Ana7ytica7 Studies.

Shah, V., Midha, K,, Dighe, 5. I McGi7very, I., Ske77y, 3- P., Tacobi, T Viswanathan, C., Cook, C., McDowa77, R., Pittman, K., & Spector, Meihods Va7 idation - Bioavai7abi7ity, Bioequiva7ence, & Pharmacokinetic Phann. Res. 9:588: 1992. Int’ 7. Jr. Pharm. 82:1: 1992 Ske77y, 3. P.: In Lieu of Humans, For In Vivo Bioequiva7ence Biodisponibilidad de Uedicamentos: Simposio InternacionaI II Agui’ les, Gai, Maria, & Me77a, Fernando. Univ of Chi7e Press Studies Editors: Page 89:

In: Arancebia, 1992 In J. Vitro

Wu, S. T., Shiu, G. K., Simmons, 3. E. , Bronaugh, R. L. ) & Ske77y, 3, P. : ReSease of Nitrog’ iycerin from Topica Products Using Artificia7 Membrances. Pharm. Sci. SlCl2) : Dec. 1992

Franz, T., Cans, E. H., FTynn, G., Higuchi, W. I., Schaefer, H., Barry,H., Conners D . , Evans, C., Krueger, G. G., Leyden, J., Maibach,H. I., Maiich, W., Nacht, S., Ng, 5 . , Peck, C., Pershing, L. K., Potts, R. 0.. Paulsen, B., Scott, R. S., Segeria, J., les & Criteria in the Deve’ lopment & Sharma, P., Ske77y, 3. P., & Wu, M. : Princip’ Optimization of Topica Therapeutic Products. Int ‘ J7. Pharm 82:21-28: 7 1992

41
stt, 5. Y., Shiu, G. K., Simmons, J. E., Viswanathan, C. T., & Ske77y, 1. P. : Performance Liquid Chromatographic Analysis of Six Conjugated and Unconjugated Estrogens in Serum. Biomedical Chromatography 6:265-268: 1992 High

Pershing, L. K. , Silver, B. 5.) Dreuger, C, G., Shah, V. P., & Skelly, J. P. : Assessment of the Bioavaifability of Betamethasone Esters in Cream and Ointment. Pharm. Res. Formu’ lations by Comparing Drug Content in Skin with a B7anching Assay. 9r45: 1992 Ske77y, J. P., Van Buskirk, C-A., Save770, D. R., Amidon, G. L., Arbit, H-M., Dighe, S . I Fawzi, M. B. , MaTic, A. W. , Ma7 inowski, H. , Nedich, R., Peck, G. E. , Shah, V. P., Shangraw, R. F. , Schwartz, 1. B. , & True7ove, 3. : Scare-Up of Immediate Release Solid Oral Dosage Forms: Pharmaceutic7al Research: 10:313:1993. Wang, J.T., 5isso7ution Worse7y, W.N., Shiu, G.K., of a very S’ lightliy So7ub7e % Ske77y, J. P. : Drug. (Submitted) Effects of June Surfactants 1992 on the

Peck, C, , Barr, W.H., Benet, L-Z., Co77ins, J., Desjardins, R. I Furst, D., Uarter, T., Rodman, J., Sananthanan, L., Schentag, J., Shah, P,, J.C., Levy, G., Ludden, Sheiner, L. B., Ske77y, J. P., Stanski, D-R., Temp’ ie, R., Viswanathan, C.T., Weissinger, J., Yacobi, A. : Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, & Toxicokinetics in Rationa Drug Development. Pharmaceutica7 Research: 9(6) : 826-833: 1992 Journal of Clinical Pharmacology: (In Press) Journa7 of Clinica? Pharmaco’ logy and Therapeutics: 5:465:1992 Journal of Pharmaceutical Sciences: 8:605:1992 International Journal of Pharmaceutics: 82:9:1992 Shah, V. P., Ske7ly, J. P., Contro'lled Re’ lease Products: 16(S) : 35-38: 2992 Ske’ lly, Eye or J. P. , Shah, Instrument? Barr, W. H., Preliminary C. Topical Dermatology. Amidon, G., Considerations. & Malinowski, H. : Pharmaceutical Induced Skin Scale-Up of Technology; Blanching -

V. & Peck, Archive of

Corticoidteroid 3-29-91.

Shah, V. P. , Flynn, G. L. , Guy, R. H., Maibach, H. I. , Schaefer, H., Ske77y, 1. P. , Wester, R. C., Yacobi, A.: Workshop Report on In Viva Percutaneous Penetration/Absorption. Washington, D. C. May 1989. Pharm. Res. S(8): 1071-1075, 1991 Int. Jr. Pharma. 74: l-8, 1991 Skin Pharmacology 4: 220-228, 1991 Thymes, N., Shah, V. P., Skelly, Transdenna 7 Therapeutic Sys terns. su, s. Y., Shiu, G. K., Simmons, Ana7ytica’ l Method for Disso7ution 211-214, 1992. 1. P. : In Vitro Release Profi’ ie 3. of Pharm. Sci. 79: 601-602, J. E., Skel’ ly, of Conjugated 3. P. : Estrogen of Estradio7 1990. II. on the Pharm. In J. Vitro 67:

Some Consideration Tablets. Int.

Wu, S-T., R. L. and Ske77y, J. P. : Shiu, G. K., Simmons, 1. E,, Bronaugh, ReSease of Nitrog7ycerin from Topica Products Vsing Artificial Membranes. Pharm. Sci . 81 (Nol2) : Dec. , 1992.

Esbe77 in B. , Beyssac, E. , Aiache, M. , Shiu, G. K. and Ske’ l?y, 3. P. : Study and Validation of a New Method of Dissolution In Vitro: The “Bio-Dis’. “ Comparison with 3 Pharm Sci. 80:991-99431991 the Rotating Bottles Method.

42
Ogger, K. E., Noory,
Resin C., Gabay, J., Shah, - Based Ora Suspension Pharmaceutical 1’ .

P.,

SkelTy, Technology

3.

P. H(9):

: Disso7ution

Profi’ fes

of

84-91, 1991. In Vitro
Pharm. Res. Procedure.

Shah, V. P., Efkins, J., tfanus, C. J., Release of Hydrocortisone from Topica 8: 55-59, 1991
su,

Noorizadeh,
Preparations;

C.,and Ske77y, J. P.:
Automated

Eva’ luation of Index Release Rate Testing s. Y., Shiu, G. K., and Ske77y, J. P.: for Gastriointestina7 Therapeutic System (GITS) Formu’ lation. 1991 E., Sager, A. O., Shiu, G, K., & Ske’ lly, 3. P.: Capi77ary Detection of Hononitrog?ycerins with Electron Capture Administration of Dinitrog7ycerins to Beag'les: Isomer-Specific

Car’ iin, A. 5. s Simmons, 3. Gas Chromatography Ana’ lyses

Fo77owing Intravenous Assay. J. Pharm. Sci.

79:649-650:1990

L. I., Carter, J7. R., Robinson, 3. Ske77y, J. P., Amidon, G. L., Barr, W. H., Benet, and In Vivo Testing and Corre'lation for Ora R . , Shah, V. P., Yacobi, A. : In Vitro Contro'l fed/Modified Re’ lease Forms. Int, J. Pharm. 63: 83-93, 1991. Pharm. Res. 7:973-9&2:1990.
J. Pharm. Sci. 79:849-854: 1990

Shah, V. P., Midha, K., Dighe, S., HcGi7very, I. J., Ske77y, J. P., Yacobi, A., Lay'loff, T., Viswanathan, C. T., Cooke, E., and.McDowa77, R. D.: Ana'lytica'l Method Validation: Bioavai7abi7ity. Bioequiva7ence and Pharmacokinetic Studies. Proceedings. Dec. 3-5, 1990. Pharmceutica7 Research. 9:588:1992. Eu. Jr, Drug Metab. & PK. 16:249:1991
Proceedings, Bio International ‘ 89: Issues in the Eva7uation of Bioavai7abi7ity Ed. McGilveray, I. J., Dighe, 5. V., French, I. W., Midha, K. K., Ske77y, 1. P. French Associates, Ontario, Canada 1990

Data. Ian

Mctitveray, I. J., Midha, K., Ske77y, 1. P., Dighe, 5. V., Doluisio, 3. T., French, I. w ., Karim, A., Burford, R.: Consensus Report from BioInternationa7 '89: Issues in the Eva’ luation of Bioavai7abi7ity Data. J. Pharm. Sci. 79: 945-946, 1990.
Ske77y, -7. P., Amidon, G. L., R . , Shah, V. P. , Yacobi , A. :

Contro77ed/Modified 849-854, 1990

I-!., Benet, L. Z., Carter, 1. R., Robinson, 3. and In Vivo Testing and Correllation for Oral Release Forms. Phatm. Res. 7: 975-982, 1990. J. Pharm. Sci. 79:

Barr, W. In Vitro

Regu7atory Recommendations in U.S. A. on Investigation and Ske77y, 3. P.: Evaluation of Ora Extended Release.Dosage Forms. Ed: Gundert-Remy, U.. and Mo77er, Wissenschaft7iche, Ver7agsgesel'lschaft, H - C, R. C. Press, 5oca Raton, F’ lorida. Skgart, Germany. Pages 175-194, 1990.

Tymes, N. H., Shah, V. P., and Ske77y, J. P.: In Vitro Re'lease Profiles of Estradio7 Transdemta7 Therapeutic Systems. J. Pharm. Sci. 79: 601-602,199O
Nguyen, H. T., Shiu, C. K., Wors7ey, W. N., Ske77y, J. P. : Disso7ution Testing Norethindrone-mestranol and Norethindrone AcetateNorethindrone-Ethiny7 Estradio'l, Ethiny7 Estradio'l Combination Tab7ets. J.of Pharm. Sci. 79: 163-167, 1990.

43 Ffartinez, R. ) Pelsor, F., Shah, V., Ske77y, _7. P., Hemmingway, S., Honigberg, I. , Ga770, 3,, Katzman, A., Zaman, R. and Schett: Effect of Dietary Fat Content on the BioavaiSabi7ity of Sustained Re7ease Quinidine C7uconate Tab7et.. Biopharmaceutics and Drug Disposition 11: U-29, 1990.
E7-Arini, 5. K., Shiu, G. K. , Ske77y, 3. P. : Theophy77ine Contro77ed Re7ease

Preparations and Fatty Food. An In Vitro Method. Pharm. Res. 7: 1134-1140, 1990.
Pefsor, Stab7e Shah, F. R., Isotopes Shah, V.P., Kasuya, to the Ana’ lyses of

Study Using the Rotating

Dia7ysis

Ce77 of

Y., Honiqberq, I. L., Ske77y, -7. P. : Application Dexamethasone Sampp'les. 3. Pharm. Sci

V. P., E’ lkins, , Lam, S. , and Ske77y, J. P. : Determination of In Vitro Drug Creams. Re7ease from ffydrocortisone Internationa7 Journa7 of Pharmaceutics 53: 53-59, 1989.
Batra, V. K., and Ske77y, Perqamon Press, Elms ford,

Yacobi, A., Deve7orJment, Shiu,

J. P. (Editors):
New York 1989.

Toxicokinetics

and New Drug

G. K., Sager, A. t?., LeMarchand, A., Ve7agapudi, R. B., & Ske77y, 3. P. : The Beaq'le Dog as an Anima7 Mode7 for Bioavai7abi7ity Study on Contro'lIedRe7ease Theophy77ine Under Influence of Food. Pharm. Res. 6: 1039-1167, 1989. for the

Aiache,

N., Beyssok, E., Prasad, V. and Ske77y, J. P. : An In Vitro Mode7 J. M., Pierre, Study of the Bioavai7abi7ity of Theophy77ine Contro77ed Re’ lease Formu'lations tinder the fnf7uence of Fatty Mea'ls. J. of Pharm. Sci. 78: 262-263, 1989.

Acampora, F. t., Robinson, J., Noorizadeh, Testing of Commercia7 Isosorbide Dinitrate Various Disso7ution Media. FDA Laboratory

C., Shah, V. & Ske77y, J. P.:
Contro77ed Re7ease Tab7ets

Disso7ution
in

and Cagsu7es

Information

Bu77etin #3290, March 1989.

Shah, V. P., Koneary, 1. J. Everett, R. L., lYcCo77o4qh, B., Noorizadeh, C. and Ske77y, J. P.: In Vitro Disso7ution Profi'le of Water Znso7ub7e Drug Dosage Forms in the Presence of Surfactants, Pharm. Res. 6: 612-618, 1989.
Ske77y, J. P. : Drug De7 ivery.

Drug Regulation
Ed. Prescott, L.

and Nove7 Drug De7ivery System, Page 341-3S2 in Nove7 F., and Nimmo, W. S., Pub. John Wiley and Sons, Release Dosage Forms
Foundation, Tokyo,

Chichester,

il. K. 1989.

Ske77y, 3. P. and Chen, T. 0.: Regu7atory Concerns in Contro77ad ProcWings of U. f. - Japan Joint Seminar: Japan Health Science
1989. Shah, V. P. I Peck, C. C., e&d Ske77y,

GIucocorticoids

- A Critique.

Editoria7

J. P. :Vasoconstriction-Skin
- Archives of

B7anch.inq - Assay for Derma+l.ogy.X25: 15!2I-1561, 1989.

Viswanathan, C. T. and Skel’ ly, 3. P. : Population Pharmacokinetics.NQhMEM and the Pharmacokinetic ScreeRs, A Requ7atory Perspective. Proceedings Symposium on "The App7ication of Popu'lation Pharmacokinetics to Drug Deve'loinnent and Wti’ lization AAPS 1st Journa7 C7inica’ l Pharmacology 29(7]: 1-6, 1989. Nationa Meeting, Washington, D. C. Ske77y, J. P. : Journa7 of Contro'lled Re7ease, Vo7. 9, No. 3, August 1989, Supp'lement No. 1, Page 2, 4.

44
Shiu, G. K., LeMarchand, Under the

Beaga7 Dog as an Animal
Theophy77ine

A., Sager, A. O., Ve7agapudi, R., and Skel?y, Mode? for Bioavaitabi7ity Study of Contro77ed Inffuence of Food. Pharm. Res. 6cl1-2): 516-519, Vitro Re’ iease Profi’ les Transdermal Patches.

3. P. : Re’ lease 1989. of C7onidine Pharm. Res. 6:

Shah, V. P., Tymes, N. W., Ske77y, J. P. : In Transderma7 Therapeutic System and Scopo7amine 346-351, 1989.

Shah, V. P. Tmes, N. W. , Merit, W. and Ske77y, J. P. : Response to Comments on the Stimuli Article “ CoSlaborative ‘ Study Resu’ lts of a Disso‘ lution Test Procedure developed by FDA for Nitrog7ycerin Transdermal Delivery Systems”. Pharm. Forum 14, 44304431, 19S8. Ske77y, 3. P. , Shah, V. P., & Schuirmannr Bioavai7abi7ity Studies: Comments on the Metr’ ier, Pharm. Res. r(5), 322, 1988. Reply articfe to ‘ Assessment by McNamera, of Variance in et a7. s by Car7 M. of a

Shah, V. P., Tymes, N. W., Ment, W. and Ske’ ily J. P. : CoI’ laborative Study Results Disso7ution Test Procedure Deve‘ loped by FDA for Nitrog7ycerin Transderma7 De7ivery sys terns. Pharmacopeia7 Forum 14, 34S8-3462, January-February 1988.

Ske77y, J. P., Bioavai7ability of Sustained Re7ease Dosage Forms Re’ lationship with In Vitro Disso’ iution, Chanter 3, pps. 57-82 in Oral Sustained Release Design and Evaluation. Formulations: Ed. by A. Yacobi and E. Ha7perin - Walega; Pergamon Press, New York, N. Y., 1988. Shah, V. P., Qmes, N. W. and Ske77y, J. P.: Comparative In Vitro Release Profile Marketed Nitroglycerin Patches by Different Disso’ iution Methods. 3. of Contro’ lled Re’ lease 7: 79-86, 1988. Shiu, C. K., Sager, A. O., Ve’ iagapudi, R. B, Prasad, Effect of Food on the Absorption of a Controlled-Re7ease Pharm. Res. 5: 48-52, 1988. V. K. and Ske7ly, Theophyl7ine J. P. : The in Mini-Swine. 3,

of

Carlin, A. S., Simmons, J. E., Shiu, G. K., Sager, A. 0. Prasad, P , * Capi77ary of Chromatographic (GC) Ana7ysis of Nitrog7ycerin Products in P7asma. Pharm. Res. 5: 99-102, 1988.

V. K. and Ske77y, and Its Denitration

Car-fin, A., Simmons, 3. E., Sager, A. O., Shiu, B. K., & Ske77y, J. P. : Capi77ary Gas Chromatographic Ana’ lysis with E’ lectron Capture Dectection of Mono Nitroglycerins Fo7 7owing IV Administration of DiNitrog7ycerins to Beag7es: Isomer-specific Metabo7 ism, J. Pharm. Sci. 79:649 1990 Car’ lin, A. 5. Prasad, if. K. p Sager, of Predniso’ lone Acetate and Re7ated Performance Liquid Chromatography. 425: 1-7, 1988. E7-Arini, Interactions Ske77y, 1. Contro77ed 5. J. P. : Analysis A. O., Simmons, J. E. and Skelly, Corticoids in Swine P’ lasma by Reversed-Phase HighJourna7 of Chromatography Biomedica’ l App7ications Study of 1. Pharm. Food-Drug 55: 25-30,

G. K. and Ske77y, J. P. : An In Vitro K. , Shiu, of Sustained-Re7ease Proprano’ lo7 Products.Int.

1988.

P. : Report on The Workshop on In Re7ease Dosage Forms, Washington,

Vitro Testing and Corre’ lation D. C., 1988.Internationa7 Jr.

for Ora Pharmaceutics

4.5 3. P. and Barr, W.: CHAPTER VIZ. Textbook entit’ led Contro77ed Drua De7ivery: Edited by J. R. Robinson and V. Lee. Marce7 Base 7 1987. Skel7y, "Regu7atoc-y Assessment”.
Pages Dekker, 294-336 2nd Edition. Inc. , New York, N. Y. , & G.,

Ske77y, J., Barr, W., Benet, L., Do77uisio, J., Go7dberg, A., Levy, Lowentha7, D., Robinson, J., Shah, V., Temp7e, R,, Yacobi, A.: Report of the Workshop on Contro77ed Release Dosage forms: Issues and Controversies. Pharm. Res. Vo7. 4, No. 1, 75-77, 1987. Shah, V., Ske77y, J. P. : Regu7atory Considerations in Transderma7 Drug De7ivery Systems Transderma7 Contro77ed Systemic Medications. Chap. 16 (399-4ZC7), Pfarce7 Dekker, New York, hf. Y. 1987. : _. in the

U.S.

Shah, V., Ymamoto, L., Schuirmann, D., E’ lkins, 3. and Ske77y, 3. P. : Ana7ysis of In Vitro Disso7ution of Who7e vs tia7f Contro77ed Re’ lease Theophy77ine Tab7ets; Pharm. Res. Vo7. 4, #5, 416-419, 1987. Ske77y, J. P., Shah, V.S., Maibach, H., Guy, R., Wester, R., Rynn, C., and Yacobi, FDA and AAPS Report of the Workshop on Princip’ les and Practices of In Vitro Percutaneous Penetration Studies: Refevance to BioavaiSabi?ity and Bioequiva7ence Pharm. Res. Vol. 4 , No. 3, 265-267, 1987. Maturu, P. K. ) Prasad, V. K., Worsley, W. hf., Shiu, G. K. and Ske??y, J. P.: The Inf7u’ lence of a High Fat Breakfast on the Bioavai7abifity of Theophyl7ine Contro77ed Re’ lease Formulations: An In vitro Exp7anation of an In Viva Observation. 1. Pharm. Sci. 75: 1205-1206: 1986. A.:

:.

Skelly, Studies. E7sevier

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Skelly, J.P., Ymamoto, L., Shah, V., Yau, Topographica Disso7ution Characterization Technique. Drug Deve’ lopment and Industria7 Pfarce7 Dekker, New York, R. Y. 1986. _’ Ske77y, -7. P., Yau, M., E7kins, Topographica Characterization G’ luconate Bioavai7abiTity. Drug Deve7opment and Industria7 Marce7 Dekker, 1986. J., Yamauto, as a Predictor Pharmacy

W., Barr, W.: for Contro77ed Re7ease Products Pharmacy 12(8&9) 1159-1175; L., of

Shah, V-S., and Barr, W. : In Vitro Sn Vivo Contro77ed Re’ lease Quinidine r~ 8 & 9) pp 1177-1201

lZ(vo7

ly, J. P. : Shah, V. P., Tyes N. W., Yamamoto, L. A., SkeT’ In Vitro Dissofution Profi7e of Transderma7 Nitrog7ycerin Internationa7 3ournal of Pharmaceutics. 32:243-250: 1986 Shah, V. P. and Ske77y, J. Regulatory Aspects Pertinent C7inica7 Research Practice New York, N. Y. 1986. P. : to the and Drug Development Regu7atory

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Ske’ Tfy, J. P. and Barr, W. : Biopharmaceutic Considerations in Designing and Eva’ uating l’ C7inica7 Research Practices and Drug Regu7atory Affairs Shah, V., Prasad, V. K., Freeman, C, , Ske77y, II, In Vitro--m Vivo Bioequiva?ence Standard Pharm. Sci. 72: 309, 1983.

Nove7 Drug De7ivery Systems. Vo7. 3, Issue 4, 1985. B. E.: Phenytoin, Part Phenytoin Capsu’ les. J. Liquid Chromatography Mass Spectrometry 10: in Drug V,and

: *:

J. P. and Cabana, for 100 mg Sodium

/

Cairns, T. S., Siegmund, E. E., Stamp, -7. 3. and Ske77y, 3. P. : Mass Spectrometry of Dexamethasone and Eetamethasone. Biomedica’ l 203, 1983.

Ske77y, J. P. and Rotenberg, K. : 0lAPTER VI: Pharmacokinetic Considerations Studies, pp 159-188. In ControfIed Drua BioavaiSabi7itv - Vo7. 2. Smo’ len, Ba77, I!.. A.: 3ohn Wi7ey and Sons, Inc. * New York, N. Y. 1983. Shah, V., Knapp, G,, Ske77y, 3. and Cabana, 5.: Measurements of Certain Drugs Due to a P7asticizer 71(103: 11, October 1982. Shah, V., Knapp, G., Caused by Plasticizers. .-, :. Ske77y, J. Tech. (i(9) Ske77y, J. Am. 3. G. :

Interference in Plasma Leve7 in Vacutainer. J. Pharm. Sci. Interference Masterfi’ les, Pharm.

P. and Cabana, B.: Drug Assay Hosp. Pharm. 39: 454, 1982. of Biopharrnaceutic

P. and Knapp, 158, 1982.

The Deve’ lopment

Shah, V. , Knapp, of Certain Drugs 2327, 1982. Ske77y, Pharm.

3. P. and Cabana, G. , Ske77y, in P’ lasma by a P’ lasticizer in of the

B. E. : Interference Vacutainers Tubes.

with Measurements Clin. Chem. 28Cll): Regulations.

3. P. : Implementation Tech. Z(l): 28, 1978.

Bioavailabi7ity

and Bioequivalence

Ske77y, 3. P.: CHAPTER, Bioavaialbi7ity Po’ licies and Guide7ines. Industria? Bioavai7abi7itv and Pharmacokinetics, Ed. by A7 fred Kartin and James 7. Doluisio, Pub. by Co77ege of Pharmacy, Drug Dynamics Institute, Austin, Texas, pgs. 2-43, May 1977.

University

of

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and Issues of Drug Interchangeability. Proceedings 48th Ske77y, 51. P. : Bioequivafence Annuair Meeting, National Association of Boards of Pharmacy and the American Association of Co77eges of Pharmacy, October 20, 1977. Ske77y,J.P.:Disso?ution _ Ske77y. 1. 539, 1976. Harter, J. (Editorial) P. : Testing:Need Bioavai7abi7ity J. for Standardization. 1. of Pharm. C7in. Tech. Pharm. I(5): Vo7, 12, 16, p. 1977.

and Bioequiva7ence.

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the P. and Steers, A. : Digoxin Vo7. XIX, p. 395, March 1974. BioTogic Avai7abi7ity (Editoria7) Vo7. 22,

Regu7a tory

Viewpoint. J. of the 9, 1973.

Ske77y, J’ P. and Knapp, G.: . American Nedica7 Association,

of Digoxin Tablets. (#2), p. 243, Apri7

47 POSTERS AND ABSTRACTS 1~ Vitro DissoTution. Wi77 The FDA allow
Pharmaceutics? 1998 Nice’ i7ar

its

J.P. Ske77y; Eastern Whippany, New 3ersey. Drug Dissolution into

Technology

use as asurrogate Meeting
of

for Clinica

Efficacy?

So7utions:

Deve7opment

and Comparison to the Fi7m Equi7ibrium Node7 with App’ Iication Facilitated Disso7ution of Carfxmazepine. Ske?7y, 3. P. Advance ACS Abstracts May 15, 1996
World Wide Prob7em; symposium * flacettepe

a Connective Differsion to Surfactant -

Mode7

Skel7y,
University.

3. P. 7th Internationa7
Ankara, Turkey Rate Tester for 3. P., Civia7e,

Pharmaceutical Sept. I994

Techno’ logy System: - FDA, Su,

Evaluation of Index Re?ease 5. Y., Skiu, G. K., Ske77y, Washington, 5. C., 1991.

Gastrointestinal Therapeutic C., Aiache, J.-M., Sigma Xi

The Effect of Membranes on Contro’ lling The Re7ease Rate of Mitrog7ycerin in Transderma7 Systems. Tymes, N., Shah, V., Skel’ ly, 3. P., Sigma Xi - FoDd and Drug Administration, Washington, D. C., 1991.
In Vitro Re7ease Rate Testing of Hydrocortisone From Creams, Shah, V. , E7kins, J., Hanus, J., Noory, C. and Ske7ly, J.P., Administration, Washington, D. C. Ointments, Sigma Xi and Lotions, - Food and Drug of

An In Vitro Study Using The Rotating Dia7ysis Ce77 Method on Food-Drug Interactions C. R. Theophyl line Products, Shiu, G. K. , El-Arini, 5. K. , & Ske77y. 1. P. I Sigma Food and Drug Administration, Washington, D. C., 1991. Disso7ution Profile of C. R. Lithium Carbonate Tab7ets By Atomic Absorption and Atomic Emission Spectroscopies H. H,, Shiu, lly, 3. P., G. K., Su, S., Parekh M. & Ske’ Administration, Washington, D. C. , 1991.

Xi -

Comparison of Li’ Determination and Ion Chromatography, Singh, Sigma Xi - Food and Drug and Propy’ lene Oxide & Ske77y, 3. P. , Sigma Ce71 Apparatus, 1991. Oxide Residues in P., AAPS 6th Annua7

Prelimimry Deve7opment Work on a Method for Determining Ethylene Residues in Plastics, Car7in, A. S. , Simmons, 3. E., Shiu G. K., Xi - Food and Drug Administration, Washington, D. C. 1991. Testing
Shiu,

Drug Re7ease
G. K., El-Arini,

from 4.

Ora Suspensions Using the Rotating and Ske77y, -7. P., AAPS 6th Annua7

Dialysis Meeting,

Deve’ lopment Work on a Method for Determining Ethy7ene and Propy7ene G. K. and Ske77y, J. Plastics, Car’ iin, A. S., Simmons, 1. E., Shiu, Meeting, Washington, D. C,, 1991. Eva’ luation of Index Release Rate Tester for Gastro-Intestina7 Formu?ations, Su, 5. Y., Shiu, G. K., Ske77y, 3. P., Civia’ le, AAPS 6th Annua7 Meeting, Washington, D. C., 1991.

Therapeutic System <GlTS) C. and Aiache, I. PI.,

An In Vitro Study Using the Rotating Dia’ lysis Ce77 Method on Focrd-Drug Interactions of Contro77ed Re'lease Theophy77ine Prod.ucts, Shiu, G. K., E7-Arini, 5. K., Ske77y, 3. P., AAPS 5th Annua7 Meeting, Las Vegas, Nevada, 1990.

48
Characterization T Amide. Su, 5isso7ution Skelly, 3. S., of Oral Amidon, Absorption G., Shah, Parameters & Degradation V. P. , and Ske77y, I. P., Profi7e, CD-a7a’ ) Peptide Las Vegas, Nevada, 1990. R., Amidon, G. L., Nevada, 1990. Tab’ lets, 3’ P. , AAPS . to Annual

of Carbamazepine into Surfactant So7utions, P. and Shah, V. P., AAPS 5th Annua? Pfeeting,

Crison, 3. Las Vegas,

Effect of Humidity Wang, 3. T., Shiu, 5th Annua7 Meeting,

and Temperature on In vivo Performance of Carbantazepine G. K., Wors7ey, W. H., Viswanathan, C. T. and Ske77y, Las Vegas, Nevada, 1990. in P.,

Fasted State Phase Re7ated Variation Humans, Chen, T. S. H., Ske77y, J. Meeting, Las Vegas, Nevada, 1990. Skin Metabo7ism Anofogs, Wu, 5. Annua7 Meeting, Studies Ske77y. on the J. P.,

Gastric Emptying in Dog and Comparison Shah, V. P. and Amidon, G. L. I AAPS 5th

of Xenobiotics: In Vitro T., Shiu, G. K., Ske77y, Las Vegas, Nevada, 1990.

Esterase Hydro7ysis of Ethyl Benzoate and Its J. P. , Stewart, R. and Rronaugh, R., AAPS 5th Liu, Meeting, H. H,, neischer, D., Las Vegas, Nevada, 1990. Prior Ohio, T., to L.C. 1990. Shiu, G. K.,

Oral Absorption Mechanism of livovudine, Shah, V., Amidon, G., AAPS 5th Annua7 for Severa Drugs in Serum Y., Shiu, G. K., and Ske’ ly, l’

Samp7e Preparation Ana’ iysis, Su., 5.

and Disso7ution Media J. P. * FACSS Meeting, Anafogs, Nevada,

In Vitro Esterase Hydro7ysis and Ske7 7y, J. P., AhPS 5th

of Ethyl Benzoate and Its Annua7 Meeting, Las Vegas,

Wu, 5. 1990.

Development of an HPLC Method for Analysis of Estradio7, Estrogens, Estrogens in Serum Samples, Su, 5. Y., Shiu, G. K., Simmons, -7. E., & SkeTly, J. P., AAPS 4th Annual National Meeting, At’ lanta, Georgia, Some Considerations on Ana7ytica7 Methods for Disso7ution of Tabyets, Su, S. Y., Shiu, G. K., Simmons, 3. E. I and Ske77y, Nationa Meeting, At7anta, Georgia, October 1989.

and Conjugated Viswanathan, C. October 1989.

T.

Conjugated Estrogen J. P. , AAPS 4th Annua? Ma, J. Meeting, J.

Contro7 of Tab7et Dissolution of Hydrocortisone with a Nonionic Surfactant, l K . , Rai’ lkar, A. I Wang,. J. T.) and Skel?y, J7. P. AAPS 4th Annua’ National Atlanta, Georgia, October 1989. Disso?ution Profi7es of Methyi Predniso’ lone Acetate Intra-Muscular Ogger, K., Santos, J., Noorizadeh, C., Shah, V., and Ske77y, J. Nationa Meeting, At’ lanta, Georgia, October 1989. Eva’ luation of Row Through and Rotating Dia7ysis Ce77 Methods for Suppositories, Shiu, G. K., Lootvoet, G., Wors’ ley, W., and Skef’ ly, Nationa Meeting, Atlanta, Georgia, October 1989. Effects of Moisture on Disso7ution of Carbamazepine Shiu, G. K., Viswanathan, C. T. , and ske7 ly, 3. P. Georgia, October 1989. Pharmacokinetic Requirements, Tab’ lets, AAPS 4th P.,

Suspensions, AAPS 4th In Vitro -7. P.,

Annua7 of

Testing AAPS 4th

Wang, 3. Nationa

T., Ong-Chen, T., Meeting, Atlanta, to FDA

Aspects of Sustained Re7ease Products with Specia7 Ske77y, 3. P., AAPS Meeting, At?anta, Georgia, 1989.

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Sustained Re7ease Nitrog?ycerine: Oral Administration to Beagles, K - t and Skelly, 9. P., 1989. Characterization Simmons, J. E., of Carlin, Its Metabo?ic Profile A. S., Sager, A. O., for 3. Following Shiu, G. of

Eva?uation of Flow Through and Rotating Dia7ysis Cel7 Methods Suppositories, Shiu, G. K. * Lootvoer, G., Worsley, W., Skelly, Meeting, Atlanta, Georgia, 1989.

In-Vitro Testing P., AAPS Annual

Effects of Moisture on Dissolution of Carbamarepine Tablets. Wang, J. T., Ong-Chen, T . , Shiu, G. K., Viswanathan, C. T. , & Skel7y, 3. P. FDA Science Expo I989 Evaluation i tories. of Flow-Thru & Rotating Shiu, G., Lootvoet, G., Dialysis Worsely, Cel7 Methods: W. I & Skelly, In Vitro Testing 3. P. FDA Science of SupposExpo 1989 T.,

Development of an HPLC Method for Analysis of Estrogens in Serum Samp7es. Su, 5. Y., Shiu, & Ske77y, 3. P. FDA Science Expo 1989 of T Ske’ lly, University

Estradiol, Estrogens, G. K., Simmons, J. E.,

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on Analytical Shiu, G. K.,

Dissolution of Conjugated Estrogens E., & Ske77y, 3. P. FDA Science Expo E., of its Car’ iin, Metabolic Profile A. S., Sager, A. Fol?owing O., Shiu,

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Proprano’ l lo’ Products. Orlando, F’ lorida 1988. Conference on Drug kbrsley, 1988. Wang, J.,

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of Ura7 Contraceptive Combination Tablets, Nguyen, H. T., Orlando, norida, and Ske77y, 3. P. 1 AAPS Annual Meeting, of Very Slight7y Water So]uble Drugs, AAPS Annual Meeting, @jando, florida, 3. P.,

Effect of Surfactants on the Dissolution Worsley, W., Shiu, G., Ske7ly, J. P., Disso7ution Noorizadeh, Automated Lotions, Or’ lando, Automated Lotions, Orlando, Profiles of Resin Based C., Shah, V. P., Ske7fy, Method for In Vitro Shah, V. P., Elkins, Rorida, 1988. Method for In Vitro Shah, V. P., Elkins, Florida, 1988.

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Suspensions in Various Media, Ogger, K., AAPS Annua7 Meeting, Or’ lando, Florida, 1988.

Re7ease of Hydrocortisones (HC] from Creams Ointments and J. S., Hanus, J. P., Skel7y, J7. P., AAPS Annual Meeting, Release of Hydrocortisones (HC) from Creams Ointments and 3. S., Hanus, I. P,, Ske?ly, 3. P., AAPS Annual Meeting, in Norethindrone/EthinyT Estradio7 G., Hunt, J., and Skelly, 3. P.,

In Vitro/In Vivo Corre7ation for Norethindrone Products, Viswanathan, C. T., Shah, A., Bradley, Annual Meeting, Orlando, Rorida, 1988. :, .,_; ”

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Pre7iminary Observations on Vasoconstriction and Bioavailability Using Various Betamethasone Va'lerate and Betamethasone Diproprionate Formu7ations, Pershing, Si 7 ver, 6. 5. , Krueger, G. G. , Shah, V. , Lam, 5. and Ske7 7y, J. , AhPS Annua7 Orlando, In Vitro Florida, 1988, Nitrog?ycerin Topicaf Products Using Artificia? Membranes, J., and Ske77y, 3. P., AAPS Annua7 Meeting, Ur7ando, Ra., Evaluation of G.. Simmons,

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Rioavai7abi7ity Study of Diazepam Products in Beagle Dog, Shiu, G. K., Sager, Carlin, A. 5. , Huang, M., Ikeda, G. J., and Ske77y, II. P., AAPS Annua7 Meeting, Or’ lando, Florida, 1988. ! i, $1 ! ;’ :-

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Characterization for Nitrog7ycerin and its Metabolic Profi’ le Fo77owing I. V. and P, Administration of h’ itrog7ycerin and Dinitrog7ycero7s to Beagles, Carfin, A, S., Simmons, J. f. , Sager, A. O., Shiu, G. K., and Ske77y, 1. P. , AAPS Annua7 Meeting, Or7ando, Filorida, 1988. An In Vitro Study of Cutaneous Metabo7ism of Proprano707, Shiu, C. K., Simmons, 1. E, , Bronaugh, R. i.. ) and Ske77y, Or’ lando, F7orida, 1988. In Vivo/ln T ., Hunt, J. Vitro P., Corre’ lation and Ske77y, of P., - An Alternative Approach, 1. P., AAPS Annua7 Meeting, Pelsor, Pharm. F., Sci. Wu, S. T., Storm, 3. E., 3. P., AAPS Annual Meeting, Dockens, Or7ando, Shah, 1987, R. C., Viswanathan, Florida, 1988.

0.

C.

Dose Proportiona7ity I and Skel?y, J. D&zmber 1987. .,,. ;’

Ora Dexamethasone, Jt. Jap. Am. Meeting

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Is Higher Agitation for a Disso7ution Products? Shah, V. P., Gurberg, M., Meeting, Ske77y, 3. P., AAPS National Study of 5isso7ution Media Re7ease Tab7et and Capsu’ le c - , Shah, V. P. and Skefly, Influence Maguire, Meeting,

Standard Necessary for Immediate Re7ease Cieri, U. R., Dighe, S., Noorizadeh, A., and Boston, Massachusetts, 1987.

for Testing Commercia7 Isosorbide Dinitrate Contro77ed Dosage Forms, Acampora, F. 7.. , Robinson, J. W., Noorizadeh, Meeting, Boston, Massachusetts, 1987. 1. P., AAPS Nationa ProfiTe of Noorizadeh, 1987. Marketed Diazepam Products, A., Ung, 7. and Ske77y, J. Shah, V. P., P., AAPS Nationa

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of pH on Dissofution 3. W., Morano, D. f., Boston, Massachusetts,

Some Considerations in Deve7oping and Dissolution Tablets, Shiu, C. K., Wors7ey, W. N., Smith, f., Meeting, Boston, Massachusetts, 1987. An In Vitro the Inf7uence Mode7 for Bioavailability ls, Prasad, of Fatty Mea’

Test for fnteric Coated Erythromycin and Ske77y, 3. P., AAPS Nationa Formu’ lations N., Aiache, Under
J-M.,

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Study on Contro77ed ReTease V. K., Ske77y, J. P., Pierre, Massachusetts, 1987.

In Viva/In Vitro Evaluation Pharmaceutics! Association,

of Topica
San Francisco,

Formulations
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HC, American

..:

51
Eva’ luation of Dissolution Methodology for Ibuprofen Tablets, VeTagapudi, R., Shah, V., E7kins, S., Hunt, J., Harter, J., and SkeTly, J., 1st AAPS Meeting in Washington, D. C.

November 3, 1986.
Capi77ary GC Analysis of Nitrog7ycerin and Its Dinitration Products in Plasma Following I. V. and P.O. Administration of Nitroglycerin - Beagles, Car’ lin, A. S., Prasad, V. K., Sager, A. 0. 5 Shiu, G. K., Simmons, 3. E., and Skelly, 3. P., AAPS 1st National Meeting, Washington, D. C., 1986. . L , ; ., ;: Standardization of Dissolution Ouderkirk, L. 1 Rippere, R., Meeting, Washington, D. C., A Nove’ Approach l for Elkins, J., Lam, S., 1986. Comparative In Vitro Dissolution Methods, Heeting, Washington, Specification, Malinowski, H., 1986. In J. Ong, T. E. * Shah, VC. P.) and Ske7Sy, 3. P., AAPS 1st Noorizadeh, National V. P., D. C. C.,

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Vitro Drug ReTease Rate from Creams, Shah, P., AAPS 1st National Meeting, Washington, Marketed Nitrog7ycerin N., and Ske?ly, 3. P.,

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Patches by Different AAPS 1st National Corre’ lations, 3. P, , AAPS Zst

Bioavailabi7ity of Topica Hydrocortisone Acetate - In vivo/ln vitro Maturu, P. K., Worsley, W. N., Prasad, V. K., Smith, E., and Ske77y, Nationa Meeting, Washington, D. C., 1986. ‘ ... ‘ i
‘ _

Deve’ iopment of a Disso7ution Prasad, V. , Smith, E, Ske77y, Effect of pH on the In Vitro K Worsley, W. N., Prasad, Wa;hington, D. C., 1986.

Test for Conjugated Estrogens Tablets, U.S. P. Maturu, P, , J. P., AAPS 1st National Meeting, Washington, D. C. 1986. Disso7ution Rate V. K., and Skel?y, of Diazepam Tablets, U.S.P., Maturu, 3. P., AAPS 1st National Meeting, Tab7ets, G. and Ske’ iy, l’ P.

Eva’ luation of Dissolution Methodo7ogy for v. P., E7kins, J. S., Hunt, 3. P., Harter, Meeting, Washington, D. C., 1986. Ana7ysis of In Vitro Disso7ution Tablets, Shah, V. P., Yamamoto, 1st Nationa? Meeting, Washington,

Ibuprofen
3.

Ve7agapudi, R. B,, Shah, 3. P., AAPS 1st Nationa ReTease Theophy77ine Ske77y, J. P., AAPS

of Whole vs Ha7ved Control7ed L. A., Schuirmann, D., Elkins,J., D. C., 1986.

of Food on Bioavai7ability of Ckmtro77ed Release Theophy’ lline Products, Zaman, Effect R Honigberg, I. L., Francisco, G. E., Stewart, 3. T., Brown, W. J7,, Kotran, 3. A., PAisor, F. R., Shah, V. P. and Ske77y, J. P., AAPS 1st Nationa Meeting, Washington, D. C. , 1986.
An Animal Mode7 for Bioavailability Study on Contro77ed-Release Formu7ations Under Inffuence of Food, Shiu, G. K., Sager, A. 0, , LeMarchand, A., Ve’ lagapudi, R. B., Prasad, V. K., and Ske17y, Meeting, Washington, D. C., 1986. J. P., AAPS 1st NationaT Disso’ lution P * , Academy of of TransdermaI Nitrog’ lycerine Pharmaceutica7 Sciences Patches,

Nationa?

Shah, Meeting,

V. P., October

Tjmes, Iv., 1985.

Ske77y,

1.

. i‘

Effects of Food on Absorption of Controlled Release Theophy77ine in Swine, Sager, A. 0. , Prasad, V. K, , Wors 7ey, W. N. , Ma turu, P. K. , and Skel7y, I. Meeting, Minneapo?is, Minnesota, 1985.

Shiu, G. K., P. , APhA -APS

52
The Influence of High Fat Breakfast on the Bioavailability of Theophy’ lline Release Formulations, Maturu, P. K. , Prasad, V. K. , Worsley, W. N. , Shiu, Skelly, 3. P. , APhA-APS Nationa Meeting, Minneao’ lis, Minnesota, 1985. Contro77ed C. , and

Preparation of High Purity Reference Standards of Nitroglycerin Denitration Products and Development of Complimentary HPLC-GC Analysis, Carl in, A. S., Prasad, V. K., Simmons, 3., and Skelly, J. P. , APhA-APS Annua’ Meeting, l Minneapolis, Minnesota, 1985. The Analysis of PrednisoTone Phase HPLC, Carlin, A. S., Annua7 Meeting, Minneapolis,
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Acetate and Related Corticoids in Swine Plasma By Reversed Prasad, V. K. , Simmons, J. , and Ske7ly, 3. P. , APhA-APS Minnesota, 1985. 4, 4 F. P, ,

Tissue Distribution, Metabolism and Pharmacokinetjcs of 2, 6- Piperjzjnedjone, Propylenedi - (+) (‘ 1, (ICRF-187) in Mice, Mhatre, R. M. I Rahman, A. , Smith, Ske77y, 3. P., and Schein, P. S., Abs. CIinica’ l Research 10: AG34, 1982. FDA and the Bioequivalent American Chemical Society Drug 180: Product, 7, 1980. Skelly, 3, P., Abs.

Pbarmacokinetics and Metabo7ic Studies Cancer Research, Mhatre, R. PI., Schein, 670, Denver, Colorado, May 1977. Biologic Availability of Digoxin Drug Inte77igence and C7inica7 Page, 186; June 1973.

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P. 24,

MONOGRAPHSAND GU.IDEUNES”

Skelly, J. P., Barr, W., Regu’ latory Assessment in Contro77ed Drug De7ivery and V. Lee 2nd Ed., Ed. : J7. R. Robinson Marcel Dekker, Inc., New York, N. Y., 1987. Ske77y, J. P. Guide7ine for the Format and Content of the and Bioavailability Section of an Application Division Staff Manual Guide, October 2986 3. P. Shah, V. P., Ske7ly, Regu7atory Aspects Pertinent Drug Del ivery Systems Oinical Research Practices Skelly, Division Release Division to the Human Pharmacokinetic

Development Regulatory of

of

Transdermal 4:433-444:1986

and Drug

Affairs

3. P. Guidelines for the Eva’ luation Drug Products Staff Manua7 Guide, April 14,

Controlled

1984.

i

53
Skelfy, J7. P., Heald, Proprano’ lol Guidance Divisioa Staff Manual P. t. Guide, 1984.

J7. P. Ske77y, P. Hepp, C. T. Viswanathan Guidance for Conducting Studies of Theophylline Contro77ed Re7ease Products, Intended for Twice a Day Dosing: Single Division of Biopharmaceutics Guideline, Apri7 1984. :;g I. P. Ske7 7y, P. Hepp, C. T. Viswanathan Guidance for Conducting Studies on Theophy77ine Contro77ed Release Products Intended for Twice a Day Dosing: Mu7tiple Division of Biophamaceutics Gwidelline, Apri7 1984. 3. P. Ske77y, P. Hepp, C. T. Viswanathan Guidance for Conducting Studies on Theophy7 7 ine Contro7 Re‘ lease Products Intended for Once a 5ay Dosing: Single Division of Biophamacewtics Gwide’ line, Apri7 1984.

Dose Study,

Dose Study,

led Dose Study,

J.P. Ske77y, P. Hepp, C. T. Viswanathan Guidance for Conducting Studies on Theophy77ine Control 7ed ReTease Products Intended for Once a 5ay Dosing: Mu‘ le ltip’ 5use Division of Biopharmaceutics Gwide7ine, Aprif 1984. J. P. Ske77y Guide7 ines for In Vivo Bioavailabi7ity Studies of Theophy77ine Conventional Dosage Forms, Division of Biophamaceutics Guide’ line, November 1983, Ske77y, J. P., Rotenberg, K. Pharmocokintec Consideration in Drug Studies Contro77ed Drug Bioavai7abi7ity Vo7. 2: Ed. by Smo?en, V. and Be77, L. A., John Wi7ey & Sons, Inc., New York, N. Y., 1980 S. V. Dighe, J. P. Ske7 7y, V. P. Shah Guidelines for In Vivo Bioavai7abi7ity Studies Drug Products Office of the Hearing Clerk, FDA, Rockvi77e, Mary’ land, February 8, 1977. Ske77y, J. P. for Anti-Convu7sant

Study,

Bioavaia7bifity Po7icies and Guide7ines In Industrial Bioavai7abi7ity and Pharmacokinetics Ed.: A. Martin and 3. T. 5o7uisio Pub. Co77ege of Pharmacy and Drug Symmics Inst. Univ. of Texas, Austin, Texas, Page 2-43, May 1977. 5. V. Dighe, J. P. Ske77y, V. P. Shah, Anti-Convwfsant Drug Bioavai7abi7ity Monograph. Reference 34, FEDERAL REGISTER, Vo7. 42, fl51, Pages 39675-9, Office of the Hearing C’ lerk, F5A, Rockvi77e, Mary7and.

54
S. V. Dighe, 3. P. Skelly, V. P. Shah Guide’ lines for Conducting In Vitro Disso7ution Anti-Convu7sant Drug Products Office of the Hearing Clerk FDA, Rockvifle, &wy?and, February 8, 1977”. J. P. Ske77y GuideTines for Carrying Out Dissolution as In Vitro Bioequivalence Requirements Office of the Herring Clerk, Rockvi77e, Tests iYary7and, Testing of

Which

Are

Classified 15, 1977.

Pfarch

3. P. Skelly, H. R. Burdock, C. M. Ise, W. Barr, S. Tricyclic Anti-depressant Drug Phonograph Office of the Hearing Clerk, FDA, August 29, 1977.
:‘ , : :

Sarver

C. M. Ise, 5. V. Dighe, 3. P. Ske7 7y Guidelines for In Vivo and In Vitro Disso?ution Testing of Tricyclic Anti-Depressants Drug Products Office of the Wearing Clerk, FDA, August 29, 1977. f. P. Ske17y, R. Temp7e, R. O’ Neil7, J. C. barter Guide7ines for Conducting Physio’ logic Bioavailabi7ity Studies on Conventiona Re’ lease, Chewabfe, and Controfted Release Anti-Angina1 Drug Products Office of the Hearing Clerk, FDA, Rockvi??e, Maryland, August II. P. Skelly, H. Ma7inowski, V. Shah, 5. Dighe Co1 laborators: C. Garcia, L. fog7 iaro, A. Ti? I, 5. Ef. Sy?vestri, R. Ba77, R. 5. Proctor, J. Michalko, K. Grant, R. Maddox, W. Gary, R. Varbe7, K. Ki?leen Glucocorticoid Drug Bioavailability Monograph. J. P. Ske77y Guide’ iines for Conducting Digoxin Bioavailability Office of the Hearing Clerk Fh)A, RockviSTe, Kary7and, Starch II, 1974, 3. P. Skelly, Procainamide C. M. Ise, V. Shah, Drug Eioavai7abi7ity 5. V. Dighe Monograph Joslyn,

31,

1977.

Studies

DUTSIDE ACKWITES Nominations Committee; Board of Directors, Mount Vernon Yacht Club. 2002 & 2003 Past Commodore, Mount Vernon Yacht Club: ZUOO-Present 2006 -Present Charter Member FDA A Iumnir Member Rules and By-Laws Committee, MVYC 2000-2003 Mt. Vernon Yacht C7ub: November, 1998 to 2000 Commodore; CEO, Mt Vernon Yacht C?ub: November, 1998 to 2000 1997 to 2000 Member of Board of Directors, #t. Vernon Yacht flub: Judge, Fairfax County School Science Fair; 1999-2002 Chair:

55
Mt. Vernon Yacht Club, Zst P7ace; Craney Is’ land Sailboat Race: Augwst, 1998 Yacht Haven Civic Association; 1980-1994 and 1996 to Present Marina Bay (Sqwantwm, Mass.) Civic Association; 1995-1997 Presenter, City Council, Qwincy, Kass. 1996-1997 Friends of Mt. Vernon Yacht C7wb; 1992-1996 Neighborhood Friends of Nt. Vernon; 1992-Present Deve7oped & Taught Course on Sailboat Racing, MWC Sail Reet 1992 Church Member (inc?uding church committees) Co Chair Mi77enniwm Committee, Mt. Vernon Yacht Club 1991 Carnegie Me77on, Senior Executive Seminar Committee 19&5-1992 Santa C7aws - NWC and Yacht Haven 1980-Present Member Mount Vernon Yacht C7wb @WC) 1977-Present #WC Sai7 Racing F7eet (Spring and Autumn Series p7ws Various Regattas) 1977~Present Owner/Pfanager , American Manaagement (Community Poo7 &znagement Firm) 1978-1987 SDME: SO OTHERS PIAY EAT; Soup Kitchen; It’ rshington, 0. C. 1982-1990 MWC Poo7 Cc#taittee 1978-1984 United States Coast Guard Auxiliary Roti77a 24-4, 1983 A’ lternate MWC Representative Chesapeake Bay Yacht C7wb Association 19131-1991 Wayne State University ATwmni Association, Capitol Hi77 Efeeting Board 1969-1981 Wayne State University Alumni Association, Washington, 0. C. Chapter 1969-1984 Member West Springfie'id Civic Association 1976-1979 to the Northern Virginia; Swim League 1970-1975 Community Representative Member Kings Park Civic Association 1969-1975 B7ock Captain, Kings Park Civic Association Annual Burke Volunteer Fire Department Fund Drive 1970-1974 Past Chairman, Kings Park Civic Association Subcommittee on Planned Land Use in Fairfax County (PLUS) 1973-1974 Past Member Springfie’ fd Magisterial District PLUS Group Officia7 N. V-S. L. t&mpetitive Swim Meets (Regwfar Season, Winter Swim, A77 Star Events) 1. Judge 1969-1971 2. Timer 1970-1974 3. Chief Timer 1972-1977 4. Stroke and Turn Judge 1974-1977 Officiaf DCCL Competitive Swim Neets (Regular Season and A77 Star Events) 1. Stroke and Turn Judge 1977-1979 2. Assistant Chief Timer 1978 A77 Star Re’ lays 1979 3. Referee 1979-1985 MWC Dock Paster '0' Dock, 1978-1982 Royal Pool Association, Board of Directors 1970-1971, 1971-1972 Manager Poo7 Concession Stand 1970-1972 FCanager Roya Combined Wfnter Swim Teams 1970-1971 and 1971-1972 Braddock Road Boys C7wb - Assistant Coach Soccer Team - 2973 & 1974 Past Member Kings Park & Kings G7en ETementary, Ho7mes Intermediate and Robinson High schoo7 PTA ‘ 5: Past Member Washington Irving Intermediate, Drake High Schoo7, and Lake Braddock High Schoo7 PTA *s Past Member West Springfiefd High Schoo7 PTA Active particfpant in numerous PTA Fun Fairs, etc. Chaired Several Interfaith Chwrch Re7ated Race Relationship Groups 1966-1968 (Project Commitment and Project Hope - Detroit, Michigan

Member; Conference on Law, Order,

and the White Back7ash;

Detroit,

Mich. 1966

FACULN MEMBER COLLEGEOF PHARNACY UNIVERSITY OF CINCINNATT AND
CONTINVING EDVCATIolv PROCRAM AND SHORT COVRSES SHORT COURSES: Center for Prafessiona’ l Advancement: SVPAC Biamua77y in New Jersey and in Amsterdam.f1996-Present). SVPAC - Short Course AAPS Annua’ Meeting; l New Or?eans, Louisianna: in Lieu 1999 of C7inica7 Efficacy

BioequivaTence and/or In Vitro University of Cincinnati Cincinnati, Ohio: 11/1.?/98 Sca’ Je-Up and Post Approva7 Solid Ura7 and Semi-So7id Percutaneous Dosage Forms University of Cincinnati Cincinnati, Ohio: H/12/98

Testing

Changes

Regulatory and Industrial Considerations, and Ana’ lytical Requirements for SVPAC Institute for Applied Pharmaceutical Science East Brunswick, New Jersey: S/18/98 Regulatory Documentation and Testing Requirements far SUPAC Institute for Appfied Phamaceutica? East Brunswick, New Jersey: S/18/98 Regulatory Requirement for ApprovaI Generic Percutaneous Dosage Forms Institute for Applied Pharmaceutica7 East 3runswick, New Jersey: S/19/98 CorreSations In- Vivo - In Vitro Co77ege of Pharmacy University of Connecticut Storrs, Cbnneticut: 9/97 FDA Requirements for Sca’ le-Up, &mediate Re’ lease and Contro77ed University of Cincinnati Cincinnati, Ohio: 11/96 Dematophamaceutics and Changing Pharmacokinetic and Pharmocodynmic ?"opica? Semi-Solid Dosage Form University of Cincinnati Cincinnati, Ohio: 11/96 Site Transfer, and Formufation Release Dosage Forms Changes for

Science of Science

Requirements

for

Studies

for Testing

57
Drug Bioavailabi7ity, Bioequiva7ence Disso7ution: Nationa Drug Manufacturing and Quafity Contro7 FDA Field Inspectors Training Course of Cincinnati DHHS - FDA - Univ. Newark, New Jersey 8/96 Individua7 University Cincinnati, Issues at Individua7 Cincinnati, Bioequiva7ence, of Cincinnati Ohio: M/95 and ffighily Variab7e & Biopkarmaceutics

Drugs

The Cutting Edge of Science Bioequivalence (IBE] vs Average Ohio: IO/95

Bioequiva7ence

In-Vitro/In-Vivo Correlations in Biopharmaceutics: “Scientific & Regu3atory Considerations” University of Cincinnati Cincinnati, Ohio: 9/93 Batch size University Cincinnati, Sca7e-Up of Solid of Cincinnati Ohio: 9/93 Ora Dosage Forms

Transderma’ l Drug De’ livery Professiona Seminar Institute 1990 Ramsey, New 3ersey Contro77ed Re’ lease Drugs Professiona Seminar Institute Baweja, R. , and Ske77v. 3. P. Ramsey, New Jersey 1989 Ora Contro77ed Re7ease Drugs Professiona Seminar Institute Ramsey, New Jersey 1989 In Vitro Disso7ution In Vivo Corre7ations S&o07 of Pharmacy Cairo University 10187 Cairo, Egypt Testing &

Drug Regulation and the Importance of In Vitro Dissofution University of ASexandria A7exandria, Egypt lo/87 Bioavai7abi7ity/Bioequiva’ lence Pharmaceutica’ l Coating and Contro77ed Re7ease Techno7ogies Symposium. Sponsored by Arno’ ld and Marie Schwartz Co77ege Sadd7e Brook, New Jersey Ray 1987 Contro’ led l’ Release Drugs Professional Seminar Institute 1987 Ramsey, New lersey

of

Pharmacy

Ora

58
Biopharmaceutic Perspective Co7Tege of Pharmacy University of Kentucky Lexington, Kentucky November

1986

Biopharmaceutics in Drug Regulations Un i vers i ty of Saskatchewan Co’ lege of Pharmacy l’ Saskatoon, Canada 1985 Biopharnraceutic Considerations in 5esign and Eva’ luation of Nave? Drug Delivery Systems University of New York at Buffa’ io Buffa’ lo, New York 1985 Postgraduate Course in Drug Development C7inica7 Pharmaco7ogy, and Regu’ lation The University of Rochester School of Medicine and Dentistry Rochester, New York 1985

Biuphanmceutics and Prescription Drug Ciba Geigy Pharmacy Intern Program
Rockvi77e, Mary’ tand 1984 Advanced Pharmacokinetics Frei Universitat Ber’ lin West Ber7in, Germany Ray, Contro77ed Co77ege of University Ranchester,

Labe’ ling

1984

Release Drug Products Pharmacy of Manchester Eng7and Ray, 1984 Drug Intern Labe’ ling Program

Biopharmaceutics and Prescription Ciba Geigy Corporation Pharmacy Rockvi7 7e, Naryland 1983

Biophamraceutic Considerations in Designing and Evaluating Nove‘ Drug 5e7ivery l Systems Academy Pharmaceutica7 Short Course: November 1983 Biopharmaceutics and Prescription Ciba Geigy Corporation Pharmacy Rockvi 7 7e, Mary’ land 1982 Drug Intern

Sciences Labe’ ling Program

59
Bioavailability and Product Selection College of Pharmacy University of Utah Salt Lake City, Utah, February 13, 1977 and Drug Substitution Drug Equivalence Academy of Family Physicians Continuing Education New Cart-o77 ton, Maryland, May 21, 1977 Role of the FDA in Bioequivalence Rhode Island Pharmacy Association and Univeristy of Rhode Is?and Providence, Rhode Island June 2,

1976 Institute

FDA Bioavailability Guidelines and Policies Pharmacy West Virginia University On Bioavailability for the Practicing Pharmacist Morgantown, West Virginia June 4, 1974

ADDITIONAL

TRAINING Officials

Relations Training for Corporate Public Facing a Hostile Enviroment Copley 80s ton, Massacheusse t ts . 1996
,‘,, -, -_

ZES Senior Washington,

Executive Leadership D. C. 1991

Forum

Tutorial on Comnunications and Public Speaking Skills for Managers and Technical Personnel San Francisco, California May 1987 Executive Excellence Program Federal Executive Institute Charlottesville, Virginia May - July When the Heat ‘ On ’ s Leadership - ‘ Daniel Management Center Washington, D. C. November 1986 Giving and Taking Criticim and Managing Washington, D. C. December 1986 The One Minute Manager Washington, D. C. December 1986 Anger

1986

60
Senior Executive Seminar Carnegie Me 7 7on University Schoo7 of Urban and Public Pittsburgh, Pennsy’ lvania Constructive Office of Washington,

Affairs Apri’ i-June

1985

Reso’ lution of Conf?ict Personnel Management D. C. Ju7y 1985

Center for Drugs & Bio’ logics Course Prevention of Sexua? Harassment August 1984 Negotiating fffective’ ly PHS Executive Seminar Series 1983 Washington, D. C. HHS Course on Human Resource Management on Employment of Disab’ led Individuals Bethesda, Mary7and 1983 Sexual Harassment for Management Parklawn Training Institute Rockvi77e, Maryland 1982 Systems Design for Management Parklawn Training Institute Rockvil le, Mary‘ land 1982 Strategic Management Management of Compfex Systems Managing Shrinking Resources The Po7itics of Change PHS Executive Seminar Series C;ai thersburg, Mary’ tand 1982 HHS Department Budgeting Hea’ lth % Human Services Washington, D. C. 1981 Process Bui7ding
I

Training

Experimenta Design and Statistics Parklawn Training Institute Rockvi77e, Mary’ land 1980 Advanced Park7awn Manassas, Project Training Virginia Officer Course Institute 1980 -

Parklawn Training Institute Rockvi? 7e, Maryland 1980 Power and Inffuence

61 Interactive Fortran IV 7 TSO - Computer Lab Park'lawn Training Institute
Rockvi7 7e, Maryland 1977

Budgeting for Managers Park'lawn Training Institute Rockvi77e, Mary7and 1976 Supervisory Management Park'lawn Training Institute Rockvi77e, Mary7and 1976 Project Officers EEO Training Park'iawn Training Ins&i tute Rockvi77e, Mary’ land 1976 Managerial Effectiveness at the Mid Leve7 Civi 7 Service Comission Washington, D. C. 2976 Pharmacokinetics and Biophamaceutics Chewionization Mass Spectroscopy University of Ca'lifornia - Schoo7 of Pharmacy 1974-197s San Francisco, Ca7ifornia Survey of Nuc'lear Medicine Park'lawn Training Institute Rockvi77e, Mary7and 1976 Supervisory Training Park'lawn Training Institute Rockvi77e, Mary'land 1974 Bioavai7abi7ity of Drugs and C7inica7 Center for Professiona Advancement New Jersey 2974 Phamacokiuetics

Workshop on Biochemica'l Pharmaco7ogy University of California - School of Medicine San Francisco, C'a7ifornia 1973 Biopharmaceutics University of Cincinnati Cincinnati, Ohio 1973 Project Officer Training Course Ohio State University/FDA Training
Working Statistics

Institute

1973 and EIanagers

for Engineers, Scientists George Washington University Schoo7 of Engineering and App'lied Sciences Washington, D. C. 1973 Bioavai'labi'i i ty FDA Training Institute Rockvi77e, Mary'land 1972

62
Solid Dosage Foms University of Wisconsin Madison, Wisconsin 1972 Nuclear Chemistry FDA Training Institute Rockville, Maryland for Chemists

1971
Law schoo7 - Graduate Division

Food and Drug Law Course
George Washington University Washington, 0. C. January

- June 1969

Clinical Psycho’ logy Amy Medical Services School Fort Sam Houston, Texas Apri7-July

1957