Library of American University of Madaba
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Development and approval of combination products : a regulatory perspective /
Authors: Siegel, Evan B.%editor Published by : Wiley, (Hoboken, N.J. :) Physical details: xii, 215 p. : ill. ; 25 cm. ISBN: 0470050942 Subject(s): United States. %Food and Drug Administration. | Drug approval %United States. | Biological products %United States. | Medical instruments and apparatus %United States. | Drug Approval %legislation & jurisprudence %United States. | Drug Combinations %United States. | Device Approval %legislation & jurisprudence %United States. Year: 2008
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| Item type | Location | Call Number | Status | Notes | Date Due |
|---|---|---|---|---|---|
 Book |
AUM Main Library | 363.1946 D487 (Browse Shelf) | Available | JBC/2012/2615 | |
| Book |
AUM Main Library | 363.1946 D487 (Browse Shelf) | Available | JBC/2012/2615 |
Includes bibliographical references and index.
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.
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