Development and approval of combination products a regulatory perspective /
में बचाया:
| निगमित लेखक: | |
|---|---|
| अन्य लेखक: | |
| स्वरूप: | इलेक्ट्रोनिक ई-पुस्तक |
| भाषा: | अंग्रेज़ी |
| प्रकाशित: |
Hoboken, N.J. :
Wiley,
c2008.
|
| विषय: | |
| ऑनलाइन पहुंच: | An electronic book accessible through the World Wide Web; click to view |
| टैग: |
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विषय - सूची:
- 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.