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 PHARMACEUTICAL SCIENCES
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I-SESSIONAL EXAMINATION
B. PHARM - VIISEMESTER

Subject: Pharmaceutical Regulatory Science

Time: 1hour
Date: 1606/2023
Max. Marks:
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II. Answer in Detail (Any ONE)
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14. Write a note on preclinical studies?
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 PHARMACEUTICAL SCIENCES
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PHARM - VIII SEM. IISESSIONAL
B.
Subject: Regulatory Sciences Time: 1 hour
Max. Marks: 30
Date: 13/07/2022

(1x 10 = 10 Marks)
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Common Technical Document.
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Answer in Brief (Any TWO) (2 x 5 = 10Marks)
drug.
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14. Explain the composition and functions of IRB.
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 SCIENCES
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subject: Regulatory Sciences Time: 1 hour
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Date: 01/06/2022

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Multiple Choice Questions (10x 1 = 10 Marks)

1. Preclinical studies address the fundamental questions about
Tolerability and| D) Preformulation study
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chemical Testing potential side
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study study
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testing
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..measures
6 Pharmaceutical regulations are the combination of legal, administrative and.
that governments take to ensure the safety, efficacy, and quality of medicines
A) Technical B) Illegal C) Quality D) Alternative
7. The drug development process usually takes.. .to complete
A) 2-4 years B) 5-6 years C)7-9 years D) 12-15 years
8. The drug discovery process initiates with the
A) Validation B) Target C) Lead D) Leadldentification
Identification optimization
9. GLP are
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10. Para |V-Challenge refers to
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patent is will expire on a patent has patent information
invalid or will particular date
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 01/06/2022
Date:
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