Development and approval of combination products a regulatory perspective /
Bewaard in:
| Coauteur: | |
|---|---|
| Andere auteurs: | |
| Formaat: | Elektronisch E-boek |
| Taal: | Engels |
| Gepubliceerd in: |
Hoboken, N.J. :
Wiley,
c2008.
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| Onderwerpen: | |
| Online toegang: | An electronic book accessible through the World Wide Web; click to view |
| Tags: |
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Inhoudsopgave:
- 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.