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Development and approval of combination products : a regulatory perspective /
A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufa.
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, N.J. :
Wiley,
©2008.
|
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 245 | 0 | 0 | |a Development and approval of combination products : |b a regulatory perspective / |c edited by Evan B. Siegel. |
| 260 | |a Hoboken, N.J. : |b Wiley, |c ©2008. | ||
| 300 | |a 1 online resource (xii, 215 pages) : |b illustrations | ||
| 336 | |a text |b txt |2 rdacontent | ||
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| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a 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. | |
| 520 | |a A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufa. | ||
| 588 | 0 | |a Print version record. | |
| 546 | |a English. | ||
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| 610 | 1 | 7 | |a United States. |b Food and Drug Administration |2 fast |
| 650 | 0 | |a Drug approval |z United States. | |
| 650 | 0 | |a Biological products |z United States. | |
| 650 | 0 | |a Medical instruments and apparatus |z United States. | |
| 650 | 6 | |a Médicaments |x Autorisation de mise sur le marché |z États-Unis. | |
| 650 | 6 | |a Produits biologiques |z États-Unis. | |
| 650 | 6 | |a Médecine |x Appareils et instruments |z États-Unis. | |
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| 650 | 7 | |a Biological products |2 fast | |
| 650 | 7 | |a Drug approval |2 fast | |
| 650 | 7 | |a Medical instruments and apparatus |2 fast | |
| 651 | 7 | |a United States |2 fast |1 https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq | |
| 700 | 1 | |a Siegel, Evan B. | |
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