JNTU
JNTU B.Pharmacy III GENERIC PRODUCT DEVELOPMENT Previous Question Paper (December-2019 - R17)
Note: This question paper contains two parts A and B. Part A is compulsory which carries 25 marks. Answer all questions in Part A. Part B consists of 5 Units. Answer any one full question from each unit. Each question carries 10 marks and may have a, b as sub questions.
Part A
What is generic product.
Answer
A generic product is a pharmaceutical product that is identical or bioequivalent to an innovator product in dosage form, strength, route of administration, quality, and performance characteristics, and is intended to be used as a substitute for the brand-name drug.
Write about generic product development.
Answer
Generic product development is the systematic process of creating a cost-effective version of an existing off-patent drug. It involves formulation development, analytical method validation, stability testing, and conducting bioequivalence studies to ensure the generic version meets the same regulatory standards of safety, efficacy, and quality as the original innovator product.
Define the therapeutic equivalent product.
Answer
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What is the main aim of process optimization?
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Explain the sampling of liquid orals.
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Write the importance of Robustness in analytical method validation.
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Explain about Activation energy calculations.
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Write about scale up of execution batches.
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Write about bioequivalence criteria.
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What is eCTD? Write briefly about eCTD.
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Part B
Explain about Hatch-Waxman Act objectives and provisions of the act.
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Write about four types of patent certification under Hatch Waxman Act and write in detail about para –IV.
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Explain about process optimization of generic product.
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Explain about packaging selection for a generic product.
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Explain about various parameters of analytical method validation.
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Explain about the sampling of in-process materials.
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Explain about accelerated stability studies of the finished dosage forms.
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Write about the expiration date calculations.
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Explain various designs of bioequivalence studies.
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Explain generic product approval process in India.
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