Development and approval of combination products a regulatory perspective /
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| 企業作者: | |
|---|---|
| 其他作者: | |
| 格式: | 電子 電子書 |
| 語言: | 英语 |
| 出版: |
Hoboken, N.J. :
Wiley,
c2008.
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| 主題: | |
| 在線閱讀: | An electronic book accessible through the World Wide Web; click to view |
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書本目錄:
- Overview of combination products development and regulatory review / Evan B. Siegel
- Detailed regulatory approaches to development, review, and approval / James Barquest
- Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings
- Clinical pharmacology and clinical development of combination products / Chaline Brown
- Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier.