Code No: 245AE R17

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

B. Pharmacy III Year I Semester Examinations, March-2021
GENERIC PRODUCT DEVELOPMENT
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Time: 3 Hours Max. Marks: 75

Answer any five questions
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All questions carry equal marks

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1. Write the need for development of generic products and explain the concepts involved
in their development. [15]
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2. Discuss the origin and development of Hatch-Waxman Act. [15]

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3. Explain the steps involved in the development of generic drug product. [15]

4. Write about factors influencing the selection of packaging material and approaches for
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optimization. [15]

5. Write about the significance of analytical method for in process samples and its
validation protocol. [15]
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6. Explain the development of analytical method for the active ingredient in the finished
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dosage form and its validation as per US FDA. [15]

7. Mention the need for scale up studies and explain the scale up studies for parenteral
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products. [15]

8. Explain the bioequivalence studies for generic drug products and criteria for acceptance
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these studies. [15]

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