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New Drug Approval Process. 5th edition
・ISBN 978-1-4200-8849-6 hard GB£ 210.00
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| 著者・編者 | Guarino, Richard A. / Guarino, Richard (eds.), |
|---|---|
| シリーズ | (Drugs and the Pharmaceutical Sciences) |
| 出版社 | (CRC Press Inc, US) |
| 出版年月 | 2009 |
| ページ数 | 548 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A00-51531＞ |
解説
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.
Updated chapters include:
- advances in international regulatory requirements, including ICH guidelines and harmonization
- a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
- the latest regulatory requirements for expediting new drug approvals
- strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development