Development and approval of combination products a regulatory perspective /
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| Korporativní autor: | |
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| Další autoři: | |
| Médium: | Elektronický zdroj E-kniha |
| Jazyk: | angličtina |
| Vydáno: |
Hoboken, N.J. :
Wiley,
c2008.
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| Témata: | |
| On-line přístup: | An electronic book accessible through the World Wide Web; click to view |
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Obsah:
- 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.