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Development and approval of combination products

Additional authors: Siegel, Evan B. | ebrary, Inc.

Published by : Wiley, (Hoboken, N.J. :) Physical details: xii, 215 p. : ill.

Subject(s): United States. -- Food and Drug Administration. | Drug approval -- United States. | Biological products -- United States. | Medical instruments and apparatus -- United States. | Electronic books.

Year: 2008

Online resources:

http://site.ebrary.com/lib/rucke/Doc?id=10296672
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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.

Electronic reproduction. Palo Alto, Calif. : ebrary, 2013. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.

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