Development and approval of combination products a regulatory perspective /
Guardat en:
| Autor corporatiu: | |
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| Altres autors: | |
| Format: | Electrònic eBook |
| Idioma: | anglès |
| Publicat: |
Hoboken, N.J. :
Wiley,
c2008.
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| Matèries: | |
| Accés en línia: | An electronic book accessible through the World Wide Web; click to view |
| Etiquetes: |
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Taula de continguts:
- 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.