Code No: 236AE R16

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

B. Pharmacy III Year II Semester Examinations, February - 2023
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GENERIC DRUG PRODUCT DEVELOPMENT
Time: 3 Hours Max. Marks: 75

Note: i) Question paper consists of Part A, Part B.

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ii) Part A is compulsory, which carries 25 marks. In Part A, Answer all questions.
iii) In Part B, Answer any one question from each unit. Each question carries 10 marks
and may have a, b as sub questions.
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PART – A
(25 Marks)
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1.a) Differentiate between innovator drugs and generic drugs. [2]
b) What is Hatch-Waxman Act? [3]
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c) What is a Reference Listed Drug (RLD)? [2]
d) What is bioequivalence? Why is it important for generics? [3]
e) Define analytical method development. Why is it carried out? [2]
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f) Discuss about in-process sampling and its importance. [3]
g) Define the term stability. Write its importance. [2]
h) List the different stability storage conditions. [3]
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i) Enumerate the designs of bioequivalence studies. [2]
j) Write in brief about bioequivalence criteria to ensure bioequivalence. [3]
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PART – B
(50 Marks)

2.a) Discuss the concept of generic drugs.

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b) Describe the different paragraphs under which generic drug application is filed. [5+5]
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3.a) Explain the important requirements of generic drugs in comparison to innovator drugs.
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b) Describe the evolution of Hatch-Waxman act. [5+5]

4.a) Explain the generic drug product development steps.

b) Discuss about formulation development process. [5+5]
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5.a) What is formula optimization? Discuss important considerations during formula
optimization.
b) Explain the importance of selecting suitable packaging materials for drug products.
[5+5]

6.a) Enlist the various parameters for analytical method validation.

b) Write in brief about linearity, range, and stability of the developed method. [5+5]
OR
7.a) Describe about verification of analytical method development for active ingredient.
b) Differentiate between verification and validation of analytical method development.
[5+5]
8.a) Explain stability studies for active ingredients.
b) Discuss the requirements of scale-up batches during optimization. [5+5]
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9.a) Explain stability studies for finished dosage forms.
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b) Describe the process of executing exhibit batches. [5+5]

10.a) Discuss the advantages of eCTD.

b) Describe the contents of Module 1 of eCTD. [5+5]
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11.a) Enlist in vitro tests carried out to ensure bioequivalence of test product.
b) Describe the drug approval process in India. [5+5]
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