Development and approval of combination products a regulatory perspective /
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| Corporate Author: | |
|---|---|
| Other Authors: | |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken, N.J. :
Wiley,
c2008.
|
| Subjects: | |
| Online Access: | An electronic book accessible through the World Wide Web; click to view |
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| 005 | 20171002055736.0 | ||
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| 008 | 080110s2008 njua sb 001 0 eng | ||
| 010 | |z 2008001360 | ||
| 016 | 7 | |z 101463351 |2 DNLM | |
| 020 | |z 9780470050941 (hbk.) | ||
| 035 | |a (CaPaEBR)ebr10296672 | ||
| 035 | |a (OCoLC)608624024 | ||
| 040 | |a CaPaEBR |c CaPaEBR | ||
| 043 | |a n-us--- | ||
| 050 | 1 | 4 | |a RA401.5 |b .D48 2008eb |
| 082 | 0 | 4 | |a 363.19/46 |2 22 |
| 245 | 0 | 0 | |a Development and approval of combination products |h [electronic resource] : |b a regulatory perspective / |c edited by Evan B. Siegel. |
| 260 | |a Hoboken, N.J. : |b Wiley, |c c2008. | ||
| 300 | |a xii, 215 p. : |b ill. | ||
| 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. | |
| 533 | |a Electronic reproduction. |b Palo Alto, Calif. : |c ebrary, |d 2013. |n Available via World Wide Web. |n Access may be limited to ebrary affiliated libraries. | ||
| 610 | 1 | 0 | |a United States. |b Food and Drug Administration. |
| 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. | |
| 655 | 7 | |a Electronic books. |2 local | |
| 700 | 1 | |a Siegel, Evan B. | |
| 710 | 2 | |a ebrary, Inc. | |
| 856 | 4 | 0 | |u http://site.ebrary.com/lib/daystar/Doc?id=10296672 |z An electronic book accessible through the World Wide Web; click to view |
| 908 | |a 170314 | ||
| 942 | 0 | 0 | |c EB |
| 999 | |c 98542 |d 98542 | ||