Development and approval of combination products a regulatory perspective /
Wedi'i Gadw mewn:
| Awdur Corfforaethol: | |
|---|---|
| Awduron Eraill: | |
| Fformat: | Electronig eLyfr |
| Iaith: | Saesneg |
| Cyhoeddwyd: |
Hoboken, N.J. :
Wiley,
c2008.
|
| Pynciau: | |
| Mynediad Ar-lein: | An electronic book accessible through the World Wide Web; click to view |
| Tagiau: |
Ychwanegu Tag
Dim Tagiau, Byddwch y cyntaf i dagio'r cofnod hwn!
|
Tabl Cynhwysion:
- 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.