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Title Development and approval of combination products [electronic resource] : a regulatory perspective / edited by Evan B. Siegel.

Imprint Hoboken, N.J. : Wiley, c2008.

Copies

Location Call No. OPAC Message Status
 Axe ProQuest E-Book  Electronic Book    ---  Available
Description xii, 215 p. : ill.
Bibliography Includes bibliographical references and index.
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.
Reproduction Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.
Subject United States. Food and Drug Administration.
Drug approval -- United States.
Biological products -- United States.
Medical instruments and apparatus -- United States.
Genre/Form Electronic books.
Added Author Siegel, Evan B.
ProQuest (Firm)
ISBN 9780470050941 (hbk.)

 
    
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