DRUG REGULATORY AFFAIRS

Preview Book

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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Estimated Delivery Time

Within Pune (1 to 2 days),
Within Maharashtra (2 to 5 days),
Outside Maharashtra (3 to 6 days) and
J&K, Ladakh and North East (5 to 8 days).

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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

Additional information
Weight 366 g
Dimensions 25 × 18 × 3 cm
Language

English

Publisher

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      Degree Pharmacy textbook
      DRUG REGULATORY AFFAIRS