Development and approval of combination products : a regulatory perspective / / edited by Evan B. Siegel.
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| Year of Publication: | 2008 |
| Language: | English |
| Online Access: | |
| Physical Description: | xii, 215 p. :; ill. |
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Table of Contents:
- 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.