Download GTU B.Tech 2020 Winter 8th Sem 2183601 Drug Delivery, Biotechnology And Validation Requirement Question Paper

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GUJARAT TECHNOLOGICAL UNIVERSITY

BE- SEMESTER-VIII (NEW) EXAMINATION — WINTER 2020

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Subject Code:2183601

Date:19/01/2021

Subject Name:Drug Delivery, Biotechnology & Validation Requirement

Time:02:00 PM TO 04:00 PM

Instructions:

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1. Attempt any FOUR questions out of EIGHT questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1

1. (a) Write a note on Radiopharmcacuticals. (03 Marks)

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2. (b) Discuss the Schedule-M guidelines for process validation (04 Marks)
3. (c) Describe the components of aerosol system with a neat-labeled diagram. (07 Marks)

Q.2

1. (a) Write a note on Drug Master File. (03 Marks)
2. (b) What are cosmetic products? Write a brief note on cosmetic products. (04 Marks)

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3. (c) Explain genetic engineering and the process involved in it. (07 Marks)

Q.3

1. (a) Define DPCO and write a brief note on it. (03 Marks)
2. (b) Write the components of Sustained Release Drug Delivery System (04 Marks)
3. (c) Explain in detail Ophthalmic drug delivery system (07 Marks)

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Q.4

1. (a) Write notes on (1). Informed consent, (2). Ethics committee. (03 Marks)
2. (b) Write the components of Transdermal Drug-Delivery System (TDDS) (04 Marks)
3. (c) Describe Liposome in detail with proper diagram. (07 Marks)

Q.5

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1. (a) Draw the basic design of fermenter. Label it properly. (03 Marks)
2. (b) What is Preformulation. Explain the steps involved in pre formulation of SRDDS (sustained release drug delivery system). (04 Marks)
3. (c) Describe NDA & ANDA (07 Marks)

Q.6

1. (a) Write a note on the aseptic operation & containment in a fermentation process. (03 Marks)

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2. (b) What are Sustained release & Controlled release dosage forms. Write the differences between these two dosage forms. (04 Marks)
3. (c) What is Schedule Y? What are the requirements & guidelines needed for schedule Y (07 Marks)

Q.7

1. (a) Write a note on recombinant DNA technology (03 Marks)
2. (b) Define aerosols and explain its evaluation tests in detail (04 Marks)

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3. (c) Describe: Sterilization of fermenter & sterilization of air supply in a fermenter with suitable diagrams (07 Marks)

Q.8

1. (a) Write a note on restriction enzyme. (03 Marks)
2. (b) What are emulsions? Explain the role of emulsifying agent. (04 Marks)
3. (c) Describe solid state fermentation. Compare solid state fermentation (SSF) & submerged liquid fermentation (SLF) (07 Marks)

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Total Marks: 56

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