| 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 |
Email on info@pragationline.com if e-book is not found.
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DRUG REGULATORY AFFAIRS
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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