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DRUG REGULATORY AFFAIRS

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Authors Name	DR N S VYAWAHARE , S C ITKAR
ISBN 13	9789380064680
Publisher	Nirali Prakashan
Edition	Seventh
Pages	318
Language	English
Publishing Year	Apr-2022

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SKU: N1629 Categories: Pharmacy Textbooks, Reference Books for BPharm, MPharm Students & Pharmacy Professionals

Print version ₹390

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Description

1 Regulatory Affair and its Importance
2 Drug Discover and Development
3 Regulatory Strategy
4 Investigational New Drug Application ( IND )
5 New Drug Application ( NDA )
6 Abbreviated New Drug Application ( ANDA )
7 Drug Master File ( DMF )
8 Orphan Drug
9 Biological Licensing Application ( BLA )
10 Registration of Drug Products in Overseas Markets
11 Pharmaceutical export
12 Regulatory Authorities and Agencies
13 Overview of Drug and Cosmetic Act
14 Regulatory Guidelines
15 Useful Information