Development and approval of combination products a regulatory perspective /
| Автор-организации: | ebrary, Inc. |
|---|---|
| Други автори: | Siegel, Evan B. |
| Формат: | Електронен |
| Език: | English |
| Публикувано: |
Hoboken, N.J. :
Wiley,
c2008.
|
| Предмети: | |
| Онлайн достъп: |
An electronic book accessible through the World Wide Web; click to view |
Съдържание:
- 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.