MPAN 10210 M.Pharmacy Degree Examinations - April, 2015

I Semester - Pharmaceutical Analysis Paper- II: Bio Assays and Statistical methods (Regulation 2010-11) Time : 3 Hours

Maximum Marks: 70

Answer all questions. 1. a) Write about any Two bioassay procedures for heparin. (OR) 2. b) Discuss about any Two bioassay procedures for vasopressin. 3. Describe any Two official bioassay methods for tetanus antitoxin. (OR) 4. Describe any Two official bioassay methods for thyroid vaccine. 5. a) Explain the concepts of sampling distribution and standard error. b) Find out the regression coefficient of Y on X from the following data: X: 1 2 3 4 5 Y: 160 180 140 180 200 (OR) 6. a) Explain the properties and applications of Normal Distribution. b) Ten competitors were ranked as following by two judges in a competition. Find the Spearman’s rank correlation coefficient. 1st Judge 2nd Judge

1 4

5 8

4 7

8 6

9 5

6 9

10 10

7 3

3 2

2 1

7. a) Explain errors of two kinds and power of a text. b) Explain two way Analysis of Variance. (OR) 8. a) Explain the procedure for testing of a hypothesis. b) The following table gives the values of effect in mg caused by three different drugs A,B and C. Determine whether there is any significant difference in the effects of the three drugs. A 12 5 7 10 B 16 10 28 26 C 30 18 35 51 Critical values from F table at 5% level of significance. n2/n1 1 2 3 8 5.32 4.46 4.07 9 5.12 4.26 3.86 10 4.96 4.10 3.71 9. a) Explain how chi-square test for independence of attributes is carried out? b) Explain the design and calculations of 33 factorial design. (OR) 10.a) Explain sign test and run test. b) Explain the design and calculations involved in Latin square design.

MPAN/MPPC/MPPH 10312 M.Pharmacy Degree Examinations - April, 2015

I Semester - Pharmaceutical Analysis/Pharmaceutics/Pharmaceutical Chemistry Paper- III: Intellectual Property Rights & Regulatory Guidelines (Regulation 2012-13) Time : 3 Hours

Maximum Marks: 70

Answer all Questions 1. Explain the criteria for getting a patent with suitable examples. What is the patent co-operation treaty? (OR) 2. Explain the different changes that had to be made to the Indian Patents and Designs Act 1970, as a result of India signing the GATT agreement. 3. Explain how a New Drug Application is filed to the Indian drug control administration. (OR) 4. Explain how a Drug Master File is prepared. 5. Explain the ICH guideline on photostability testing of New Drug Substances and Products (QIB). (OR) 6. Explain the ICH guideline on Evaluation of Stability Data (QIE). 7. Explain the FDA guideline Dissolution testing of immediate release solid oral dosage forms. (OR) 8. Explain the FDA guideline on Bioanalytical Method Validation. 9. Discuss the effect of food on bioequivalence studies. (OR) 10. Discuss how in vitro dissolution testing is carried out and documented as a part of scale up and approval changes.

MPAN/MPPC/MPPH/MPRA 10112 M.Pharmacy Degree Examinations - April, 2015

I Semester - Pharmaceutical Analysis/Pharmaceutics/Pharmaceutical Chemistry/ Drug Regulatory affairs Paper- I: Chromatographic Methods of Analysis (Regulation 2012-13) Time : 3 Hours

Maximum Marks: 70

1. a) Explain the process of mass fragmentation and the underlying principle in GC-MS. Discuss with selected examples. (OR) b) Outline the basic principle, instrumentation and applications of LC-MS in pharmaceutical analysis. 2. a) Write an account of i) Chiral separations in HPLC ii) Column packings in HPLC (OR) b) i) Advantages of UPLC ii) Detectors used in HPLC 3. a) What is electrophoresis? Give an account of different types of this technique and their applications in pharmaceutical analysis. (OR) b) Explain the principle, instrumentation and applications of HPTLC in analysis of drugs and pharmaceuticals. 4. a) Explain the process of method development, optimization and validation using GC-MS. (OR) b) Discuss the analytical method development, optimization and validation by LC-MS. 5. a) Give an account of the following in pharmaceutical analysis: i) Membrane filtration (OR) ii) Liquid-liquid extraction.

MPAN/MPRA 10212 M.Pharmacy Degree Examinations - April, 2015

I Semester - Pharmaceutical Analysis/Drug Regulatory Affairs Paper- I: Bio Statistics & Biological Standardization (Regulation 2012-13) Time : 3 Hours

Maximum Marks: 70

1. a) Discuss about the bioassay of insulin. (or) b) Describe in detail about the official bioassay of pencillins. 2. a) Explain the principle, formulae in different situations and applications of Z test. (or) b) Three groups of persons were administered with Placebo, herbal drug and synthetic compound for their blood pressure. They were observed for control of hypertension and were categorized as given below. Determine whether there is any association between control of BP and type of drug administered.

Placebo Herbal formulation Synthetic drug Total

Number with hypertension 50 40 20 110

Number without hypertension 50 60 80 190

Total 100 100 100 300

Critical values of X2 at 5% level of significance. n 1 2 3 4 5

X2 value 3.84 5.99 7.81 9.49 11.07

3. a) Explain signed rank test and run test. (or) b) Explain Kruskal Walli’s test and median test. 4. a) Explain Randomised Block Design. What are probits? (or) b)Write notes on principle and calculations of factorial experiments. What is dose-effect relationship? 5. a) Explain the method of least, squares and the calculation of Pearson’s correlation coefficient. (or) b) Explain the concept and calculations involved in multiple regression.

MPAN104/MPPC 10412 M.Pharmacy Degree Examinations - April, 2015

I Semester - Pharmaceutical Analysis/Pharmaceutics Paper- IV: Preformulation Studies in Product Development (Regulation 2012-13) Time : 3 Hours

Maximum Marks: 70

Answer all questions 1. Enumerate the role of biopharmaceutical factors in the preformulation studies. OR 2. Explain the causes for reductive and photolytic degradation of drugs with suitable examples and protective measures for the same. 3. Write about different types of possible impurities in mew drug products and their limits as per Q3B. OR 4. Discuss about the sources of impurities in APIs and mention the threshold values. 5. Explain the approaches for the selection of mobile phase in HPLC method development. Mention the significance of inter-day intra-day stability of HPLC method. OR 6. Explain the differences in conducting forced degradation studies for drug substances and drug products. What are the advantages of these studies? 7. Explain the properties of drugs influencing the selection of dissolution test apparatus and key operating parameters. OR 8. Write about the approaches for dissolution medium selection for maintaining sink condition. What is the significance of discriminating dissolution medium? 9. Explain the product development approaches for tablets. OR 10. Write about the characteristics of bases influencing the formulation development of semisolid dosage forms.

MPPC 10212 M.Pharmacy Degree Examinations - April, 2015

I Semester - Pharmaceutics Paper- II: Advanced Physical Pharmaceutics (Regulation 2012-13) Time : 3 Hours

Answer all questions

Maximum Marks: 70

5 x 14 = 70

1. a) Write the reasons why polymorphism is exhibited by some compounds. Add note on crystal hydrates. b) Differentiate between amorphous and crystalline solids. Write the factors affecting crystallization. (OR) 2. Describe in detail about different techniques employed in preparation of solid dispersions with examples. Add note on contact angle. 3.

4.

5.

6.

7.

8.

9.

10.

Write in detail about Hildebrand solubility parameters and explain how these are useful in predicting the miscibility of hydrogen bonding or non-hydrogen bonding solvents. (OR) Discuss in detail about the influence of solvents on the solubility drugs. Explain the influence of surfactants on solubility. List various diffusion driving forces in pharmaceutical systems and describe any two forces in detail. (OR) What do you understand by the term diffusivity and describe the factors affecting it in liquids. Add note on biological diffusion. Discuss in detail about compression forces involved during tablet compression process and add note on tablet properties related to tablet compression process. (OR) Explain with example that how nature of materials will influence the compression process. Add note on significance of Heckle equation. Explain in detail about the method of accelerated stability testing of pharmaceutical product. Add note on photo degradation of drugs. (OR) Discuss in detail about the factors affecting drug stability of solid dosage forms with examples. Add note on the equation related to the effect of temperature on reaction rate.

MPPH 10212 M.Pharmacy Degree Examinations - April, 2015

I Semester - Pharmaceutical Chemistry Paper- II: Advanced Organic Chemistry-I (Regulation 2012-13) Time : 3 Hours

Maximum Marks: 70

MPPH 10412 M.Pharmacy Degree Examinations - April, 2015

I Semester - Pharmaceutical Chemistry Paper- IV: Pharmacological Screening Methods (Regulation 2012-13) Time : 3 Hours

Maximum Marks: 70

MPRA 10312 M.Pharmacy Degree Examinations - April, 2015

I Semester - Drug Regulatory Affairs Paper- III: Drug Development & Approval Process (Regulation 2012-13) Time : 3 Hours

Maximum Marks: 70

Answer all questions. 1. Discuss the challenges involved in developing a generic equivalent for a drug candidate with poor solubility and poor permeability. (OR) 2. Write a note on the life cycle management of a generic drug product. 3. Explain the different strategies used by large pharmaceutical companies to develop a new formulation and to introduce it into the market. (OR) 4. Explain how interdisciplinary teams operate in developing new generic products. 5. Taking example of “discovery of novel targeted liposomes for a cancer drug”, explain how a patent application is written, including claims? (OR) 6. Explain the words “prior art”, “provisional application”, “inventor”, “obviousness”, “infringement” and “claim”. 7. Write a note on WHO certification scheme on the quality of pharmaceutical products. (OR) 8. Explain the “National Pharmacovigilance Programme”. 9. Explain how trade related aspects of Intellectual Property Rights (TRIPS) influenced the Indian pharmaceutical industry, with respect to the introduction of new drugs. (OR) 10. Write a note on trademarks and copy rights.

MPRA 10412 M.Pharmacy Degree Examinations - April, 2015

I Semester – Drug Regulatory Affairs Paper- IV: Current Good Manufacturing Practices (CGMP) and Documentation (Regulation 2012-13) Time : 3 Hours

Answer all questions

Maximum Marks: 70

(5 x 14 = 70)

1. Differentiate between ‘GMP’ & ‘cGMP’. Write notes on schedule M. Add note on in process quality control. (OR) 2. Write in detail about WHO-GMP requirements on pharmaceutical manufacturing. Write the concept of total quality management. 3. Describe about the GMP requirements for design, construction and plant lay out and environmental control. Add note on class 100 area. (OR) 4. Discuss about Good Warehousing practices in pharmaceutical industry. Add note on maintenance of sterile area 5. Discuss about the contents in batch formula record and how it differs from master formula record. (OR) 6. Write notes on common technical documentation and electronic common technical document. Add note on drug master files. 7. Discuss the labeling and packaging requirements for injectables and tablets in regulated markets. (OR) 8. Discuss the labeling and packaging requirements for capsules and oral liquids in non regulated markets. 9. Explain briefly about Consumer Protection Act — 1986. (OR) 10. Write about the Environmental Protection Act -1986