Code No: 245AE R17

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

B. Pharmacy III Year I Semester Examinations, October/November-2020
GENERIC PRODUCT DEVELOPMENT
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Time: 2 Hours Max. Marks: 75

Answer any five questions

All questions carry equal marks
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1. Write about Hatch-Waxman Act and its amendments. [15]

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2.a) Write about history of development of generic drug product in US.

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b) Give the differences between generic drugs and branded drugs. [15]

3. Explain the steps involved in the development of generic product equivalent to

reference listed drug. [15]
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4. Discuss the approaches for process optimization and packaging selection. [15]
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5. Explain the validation of analytical method developed for active ingredient. [15]

6. Mention need for development of analytical method for estimation of finished dosage
forms in development of generic products and discuss the challenges involved in it.
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[15]

7. How the scale up studies are carried out for exhibit batches of solid dosage forms. [15]

8. Write about different statistical designs used for carrying out bioequivalence studies
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highlighting their relative merits. [15]

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