JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B.Pharmacy III Year GENERIC PRODUCT DEVELOPMENT Previous Question Paper (July/August - 2023 - R17)
Note: i) Question paper contains two parts, Part A, Part B. ii) Part A is compulsory which carries 25 marks. Answer all questions in Part A. iii) In Part B answer any one question from each unit. Each question carries 10 marks and may have a, b as sub questions.
Part A
Differentiate between innovator drugs and generic drugs.
Answer
An innovator drug is the first version of a medicine approved by regulatory authorities based on extensive clinical trials proving safety and efficacy. A generic drug is a pharmaceutical product designed to be bioequivalent to the innovator drug in dosage form, strength, route of administration, and intended use, typically marketed after the innovator's patent expires.
Write the full form of Hatch-Waxman Act?
Answer
The full form of the Hatch-Waxman Act is the Drug Price Competition and Patent Term Restoration Act of 1984.
What is a Reference Listed Drug (RLD)?
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What is bioequivalence? How is it measured?
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Define analytical method development. Why is it carried out?
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List the differences between validation and verification.
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Write the importance of stability studies.
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What is an exhibit batch? Why is it taken?
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Write about regulatory authority of India approving the drugs.
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Enlist bioequivalence criteria to ensure bioequivalence.
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Part B
What are generic drugs? List the similarities between generic and innovator drugs.
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Describe in brief the development of generic drugs.
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Discuss the enactment of Hatch-Waxman act.
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Enlist the different paragraphs under which generic drug application can be filed.
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Explain the generic drug product development steps.
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What is formula optimization? Discuss important considerations during formula optimization.
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Discuss about designing generic drug to meet RLD requirements.
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Explain the importance of selecting suitable packaging materials for drug products.
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List the parameters to be considered during analytical method validation.
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Write in brief about linearity, range and stability of the developed method.
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Describe verification of analytical method development for active ingredient.
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Differentiate between verification and validation of analytical method development.
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Describe the conduct of stability studies for active ingredients.
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How are the scale-up batches optimized?
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Describe the conduct of stability studies for finished dosage forms.
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How the exhibit batches executed?
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Why eCTD submissions are advantageous over other CTD submissions?
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Describe the contents of Module 2 of eCTD.
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Enlist in vitro tests carried out to ensure bioequivalence of test product.
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Describe the drug approval process in the USA.
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