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

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

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

efficiency of column. Case studies on Q. p-dimethylamino benzaldehyde/ cinnamaldehyde (PDAB). usage. Experiments based on application of the following reagents in pharmaceutical analysis: 2. GC./QA/2nd/Syllabus/ 2011-12//003 4 .5-triphenyltetrazolium salt. diazepam.benzothiazoline hydrazone hydrochloride (MBTH).2.2.2–napthaquione-4-sulfate. characterization. instrumentation. selectivity.5-triphenyltetrazolium salt. p-dimethylamino benzaldehyde (PDAB)/ cinnamaldehyde (PDMAC). Qualitative and quantitative determination of various drugs in biological fluids (blood. internal standard method).3. instrumentation and application of Laser. storage and records. (PDMAC). urine) – barbiturates. Folium ciocalteu reagent. adrenaline. Analysis of drugs obtained from genetic engineering: Vaccines. 1. Ninhydrin reagent. TCA. Pharm. Practical 90 Hrs. lab planning and analytical reporting of raw materials. (Quality Assurance) Second semester M. pethidine. 2–napthaquione -4. C. 3 – methyl -1. Pharm. classification. 2. Laser: Basic principles. hydantoins.6– dichloroquinone chlorimide.6– dichloroquinone chlorimide. amphetamine. resolution. Polarography: AC pulse polarography and square wave of polarography. morphine. ninhydrin reagent. Experiments using HPLC.Principles and procedures involved in using the following reagents in pharmaceutical analysis: 2. sulpha drugs. DTA and DSC theory.benzothiazoline hydrazone hydrochloride (MBTH). interpretation of spectra and applications.3. HETP. instrumentation of thermographs and application. Separation by electrophoresis.QA124P Advanced Pharmaceutical Analysis-Method Development. in process and finished goods. Gradient elution techniques in column chromatography. 2. Estimation of single component or multicomponent drugs in formulations–using different methods of quantitative analysis (Direct comparison method. (Quality Assurance) Second semester MGCPS//M. Folium ciocalteu reagent. Two dimensional paper chromatography and TLC. M.Ph. asymmetric factor. calibration curve method. Reference standards: Source. Thermal Methods of Analysis: Introduction. 1. Electron Spin Resonance: Principle. Effect of polarity of mobile phase on retention of samples in normal/ reversed phase mode in HPLC.sulfate. M. HPTLC: Determination of chromatographic parameters– capacity factor. sera and toxoids. preparation. 3–Methyl1.

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

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

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