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M. Pharm.

(Quality Assurance) TEACHING AND EXAMINATION SCHEME Second semester
Paper No. M.121T M.122P Subject Advances in Pharmaceutical Sciences including Biostatistics, Theory Advances in Pharmaceutical Sciences including Biostatistics, Practical Advanced Pharm. AnalysisMethod Development, Theory Advanced Pharm. AnalysisMethod Development, Practical Total Quality Management-II, Theory Professional Practice Total
* These hours will not be counted as workload of Teacher.

Teaching Hours/ Week 4 6

Univ. Exam Hrs. 3 6

Sessio nal 25 25

Marks Univ. Exam 75 75

Total 100 100

M.QA123T M.QA124P M.QA125T

4 6 4 12* 36

3 6 3 -

25 25 25 125

75 75 75 375

100 100 100

500

MGCPS//M.Ph./QA/2nd/Syllabus/ 2011-12//003

1

Animal experiments for determination of activity. non obviousness in patent. solid stability. Wilcoxon signed rank test. accelerated studies and shelf life assignment. drafting of patent claims. protocol for physical stability testing program. Introduction to ‘The Patent Act 1970’ as amended in 1999. standard deviation and coefficient of variation. (Pharmaceutics. mono or polyherbal formulations by F. Patents: Definition. chisquare test.D. phytomorphology. Biostatistics: The application of the following in pharmacy shall be covered. IR. MGCPS//M. introduction to control charts. Pharmacopoeial methods for evaluation of crude drugs. parameters for physical stability testing. Theory 60 Hrs. L. anti-inflammatory agents. Parameter studies for physical stability of drugs. TLC. with special emphasis on the forms to be submitted along with a patent application. ash values.122P Advances in Pharmaceutical Sciences including Biostatistics.Computer AIDED Analysis. types of patents. The essential elements of patent. median and mode. Practical 90 Hrs./QA/2nd/Syllabus/ 2011-12//003 2 .M. need for patenting. conditions to be satisfied by an invention to be patentable. evolution of full and reduced mathematical models in experimental designs. scope and aims of preclinical and clinical trials for drugs and dosage forms. HPLC. tranquilizers.M. one way ANOVA. M. Introduction to various stages in process of drug development. determination. Pharm. quantitative microscopy. automated analysis .O.121T Advances in Pharmaceutical Sciences including Biostatistics. Biological evaluation of the following classes of drugs: analgesics. GLC. brief introduction to trademark protection and WTO patents. students t-test. Shelf life study of formulations. Pharmainformatics: Introduction to information resources available on the internet for the various subjects in pharmacy. 2002 & 2005 and the rules made there under. Drug stability: Solution stability.Ph. extractive value. Pharmacology) COMMON SUBJECTS Second semester M. regression analysis. Quality Assurance. qualitative analysis. Experimental Designs: Introduction to full factorial designs.. bioavailability-cross-over study. introduction to contour plots. & HPTLC etc. probability. hypoglycemic agents and diuretic agents. microbial content determination and evaluation by other advanced methods like UV. important patent related web-sites.O. Guidelines for preparation of laboratory notebook. central composite designs. potency and toxicity of drug substance and dosage forms. applications of the experimental designs for the subjects mentioned under pharmainformatics. microscopial methods.. frequency distribution. introduction to patent search. Mean. pesticide analysis.

X-ray Diffraction Methods: Introduction. median. Theory 60 Hrs. separation. MGCPS//M. HPTLC–instrumentation and applications. column efficiency parameters. Evaluation/ standardization of extracts based on WHO guidelines. immunoaffinity. Radiochemical Assays: Sodium iodide. ion-exchange amino acid analysis. immumofluorescence. Cumulative percentage drug release. Supercritical Fluid Chromatography (SFC). Detectors: FID. efficiency parameters. Chromatographic Techniques: HPTLC detection methods. Gas Chromatography: Instrumentation. hydrophobic interaction chromatography. Practical exercises based on biostatistics and statistics in clinical research. alkylation and esterification. papain. comparison of sensitivity. standard deviation. linear regression. M. Radioimmune assays of drugs and hormones. programmed multiple development techniques. preparative and micro-bore columns. Miller indices. liquid stationary phases. calculation of Rf value. perfluoroacylation. obtaining and interpretation of X-ray powder diffraction data. A critical comparison of sensitivity. cyanocobalamin and quality control of radiopharmaceuticals. amino acid sequence analysis. size exclusion. column selection. the Van Deemter equation. TCD. ECD.Ph. mean. reverse-phase HPLC. (Quality Assurance) Second semester M. first and second order equations. selectivity and field of applications of these detectors. purification and identification of important phytoconstituents. hyaluronidase. normal and reversed-phase packing materials. Enzyme Analysis: Pepsin.Evaluation of crude drugs. quantitative methods in TLC. elementary crystallography. Isolation. instrumentation in HPLC. NPD. HPLC–tryptic mapping. generation of X-ray. Bragg’s law of X-ray powder diffraction. Detectors in HPLC: refractive index. Pharm. mobile phase selection. derivatisation methods of GC including acylation. photometric and electrochemical. Liquid Chromatography: Comparison of GC and HPLC. Preparing protocols on various validation requirements. packed and open tubular column. and other simple programs of pharmaceutical interest./QA/2nd/Syllabus/ 2011-12//003 3 . Immunological Assays: ELISA. immunoblotting. analytical.QA123T Advanced Pharmaceutical Analysis-Method Development. Chi–square test. resolution. selectivity and field of applications of these detectors. one-way ANOVA. mode. X-ray powder diffractometer. Examples of applications of GC in pharmaceutical analysis. resolution. X-ray diffraction. Practical exercises based on Student ‘t’ test. Stoke’s linear trapezoidal rule.

Laser: Basic principles. diazepam. ninhydrin reagent.3.6– dichloroquinone chlorimide. GC. lab planning and analytical reporting of raw materials. adrenaline. 1. Electron Spin Resonance: Principle.5-triphenyltetrazolium salt. preparation. storage and records. 3 – methyl -1. M. in process and finished goods.2–napthaquione-4-sulfate. Thermal Methods of Analysis: Introduction.2. (Quality Assurance) Second semester M. Pharm. Effect of polarity of mobile phase on retention of samples in normal/ reversed phase mode in HPLC. Reference standards: Source. instrumentation and application of Laser. Gradient elution techniques in column chromatography. pethidine. Two dimensional paper chromatography and TLC. (Quality Assurance) Second semester MGCPS//M. efficiency of column. (PDMAC). HETP. Folium ciocalteu reagent. Estimation of single component or multicomponent drugs in formulations–using different methods of quantitative analysis (Direct comparison method. DTA and DSC theory. 2.3. Folium ciocalteu reagent. 3–Methyl1.2. Experiments based on application of the following reagents in pharmaceutical analysis: 2. hydantoins. sulpha drugs. resolution. calibration curve method. sera and toxoids. p-dimethylamino benzaldehyde/ cinnamaldehyde (PDAB). selectivity. 2–napthaquione -4. instrumentation of thermographs and application. Polarography: AC pulse polarography and square wave of polarography. asymmetric factor. TCA. Analysis of drugs obtained from genetic engineering: Vaccines. M. instrumentation. interpretation of spectra and applications.sulfate. Pharm. usage. urine) – barbiturates. internal standard method).6– dichloroquinone chlorimide. Practical 90 Hrs.benzothiazoline hydrazone hydrochloride (MBTH).5-triphenyltetrazolium salt. Qualitative and quantitative determination of various drugs in biological fluids (blood. Separation by electrophoresis.Principles and procedures involved in using the following reagents in pharmaceutical analysis: 2. 2. C./QA/2nd/Syllabus/ 2011-12//003 4 .Ph. classification. HPTLC: Determination of chromatographic parameters– capacity factor. morphine.QA124P Advanced Pharmaceutical Analysis-Method Development. Ninhydrin reagent. 1. characterization. amphetamine. Case studies on Q. p-dimethylamino benzaldehyde (PDAB)/ cinnamaldehyde (PDMAC). Experiments using HPLC.benzothiazoline hydrazone hydrochloride (MBTH).

Validation of processes: Mixing. Validation of system and analytical procedures (as per ICH or Pharmacopoeia). Environmental Protection Act. compression. Factories Act. Factory Procedures: Standard operating procedures MGCPS//M. Recent amendments to Drugs and Cosmetic Act and other relevant rules. Validation of water purifying systems (demineralised water. manufacturing and control requirements of NDA. Regulatory aspects of pharmaceutical and bulk drug manufacture. benefits.Ph. content of investigator brochure. autoclaving. Quality. validation protocol. Schedule U requirements. content and format of NDA. safety and legislation for cosmetic products. Quality. process characterization and optimization. granulation. Validation of computer aided instruments. objective and protocol design. regulatory drug analysis. Product development stage documentation. types of process validation. Loan license (contract manufacture) auditing. Theory 60 Hrs. Approval of New Drug: Investigational new drug (IND) submission. Validation and security measures for pharmaceutical data processing. safety and legislation for herbal products. Relevant provisions of Consumer Protection Act. format and content of IND. membrane filtration. filtration. reviews and approval of a clinical study. cleaning validation.M. Introduction to Patent Act. drying. clinical research protocols. Certification and licensing procedures. Validation of sterilization methods and equipments: Dry heat sterilization./QA/2nd/Syllabus/ 2011-12//003 5 . distilled water and water for injection). Elements of validation. filling. specific requirements. general consideration of the new drug approval (NDA). FDA guidelines for clinical trials. Validation and calibration of equipments and instruments.QA125T Total Quality Management-II. Validation of air handling equipments and facilities in sterile and non-sterile areas. gaseous sterilization and sterilization by radiation.

Standard test procedures. Manufacturing documents. Cleaning methods.Ph. Retention samples and records. Batch release documents. Distribution records. Complaints and recalls. Quality control documentation./QA/2nd/Syllabus/ 2011-12//003 6 . MGCPS//M.