JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B. Pharmacy III GENERIC PRODUCT DEVELOPMENT Previous Question Paper (January / February - 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
What do you mean by reference listed drug?
Answer
A Reference Listed Drug (RLD) is the drug product identified by the FDA as the standard to which a generic drug must be compared for safety and efficacy, usually the innovator drug product approved under a New Drug Application (NDA).
List out the parameters that should be same as the innovator for developing any generic drugs.
Answer
The parameters that must be identical to the innovator include:
- Active Pharmaceutical Ingredient (API)
- Dosage form
- Strength
- Route of administration
- Quality, safety, and efficacy standards
Why is it important to assess the manufacturing feasibility in pharmaceutical industries?
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What is the importance of target market selection in developing generic products?
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Write the components of validation master plan.
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Define Accuracy, Precision and Specificity.
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What are accelerated conditions?
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Write the importance of scale up studies.
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What is Common Technical Document and how many modules are there in it?
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Write the criteria of bioequivalence studies.
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Part B
Discuss the concept of generic drug product development.
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Differentiate innovator and generic drug products.
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Explain US FDA criteria for a generic drug product.
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Explain the formula optimization and process optimization techniques in generic product development.
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Elaborate the excipient selection approach and designing of formulation method for generic product development.
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Describe the analytical method development and validation for in-process samples.
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What do you mean by method development and how is it validated?
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Briefly discuss various methods of stability testing of active ingredients.
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Explain in detail about the scale up processes in the compression of powder.
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Explain the crossover design for bio-equivalence studies and mention the advantages and disadvantages of such design.
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Details about the drug product approval process in US.
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