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Code No: 236AE
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
B. Pharmacy III Year II Semester Examinations, July -2021
GENERIC DRUG PRODUCT DEVELOPMENT
TU
Time: 3hours Max.Marks:75
Answer any five questions
All questions carry equal marks
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H
1. Discuss steps in generic drug product development. [15]
U
2. Write notes on Hatch-Waxman act. [15]
SE
3. Discuss Design of dosage form to meet equivalence to reference listed drug in
detail. [15]

4. Discuss product development steps in detail. [15]

D
5. Discuss Analytical method development for verification and validation of an
active ingredient. [15]
PA
6. Discuss Analytical method development for in-process samples in detail. [15]

7. Discuss stability studies at different conditions in detail. [15]

PE
8. Discuss bioequivalence criteria and in-vitro tests to ensure bioequivalence of test
product. [15]
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