Development and approval of combination products a regulatory perspective /
-д хадгалсан:
| Байгууллагын зохиогч: | |
|---|---|
| Бусад зохиолчид: | |
| Формат: | Цахим Цахим ном |
| Хэл сонгох: | англи |
| Хэвлэсэн: |
Hoboken, N.J. :
Wiley,
c2008.
|
| Нөхцлүүд: | |
| Онлайн хандалт: | An electronic book accessible through the World Wide Web; click to view |
| Шошгууд: |
Шошго нэмэх
Шошго байхгүй, Энэхүү баримтыг шошголох эхний хүн болох!
|
Агуулга:
- 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.