RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
Rajiv Gandhi University of Health Sciences
First Semester M. Pharmacy Degree Examination
[Time: 3 Hours] [Max. Marks: 75]
Product Development and Technology Transfer
Q.P. CODE: 5104
Your answers should be specific to the questions asked.
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Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- What are the contents of New Drugs Application (NDA)?
- Define Solubility. Discuss the different methods to improve the solubility.
- Explain various parameters to be considered during selection of Glass as a primary container system for Pharmaceutical dosage form.
- Discuss the various Optimization parameters to be considered during Technology transfer.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Write a note on Bulk Active Chemical Post Approval Changes (BACPAC) Guidelines.
- Write a note on Clinical research process.
- How is a polymorphic form of drugs deduced? Why it is essential in formulation development?
- Explain characterization techniques for determination of particle size and surface area.
- Why is scale up of production processes essential?
- Explain the protocol for pilot plant scale up for liquid dosage forms.
- What are the parameters to be considered during mixing of solids during Pilot plant scale up?
- Define and explain primary and secondary packing materials.
- Discuss the various Issues faced during modern drug packaging system.
- Write a note on Development report.
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