Development and approval of combination products a regulatory perspective
| Formato: | Libro electrónico |
|---|---|
| Idioma: | Inglés |
| Materias: | |
| Acceso en línea: | Acceso restringido con credenciales, usuarios UPSA |
| Ver en Biblioteca de la Universidad Pontificia de Salamanca: | https://koha.upsa.es/cgi-bin/koha/opac-detail.pl?biblionumber=727396 |
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Tabla de Contenidos:
- 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.
