Development and approval of combination products [electronic resource] : a regulatory perspective / edited by Evan B. Siegel.
Contributor(s): Siegel, Evan B | ebrary, Inc.
Material type:
BookPublisher: Hoboken, N.J. : Wiley, c2008Description: xii, 215 p. : ill. ; 25 cm.Subject(s): United States. Food and Drug Administration | Drug approval -- United States | Biological products -- United States | Medical instruments and apparatus -- United StatesGenre/Form: Electronic books.DDC classification: 363.19/46 Online resources: An electronic book accessible through the World Wide Web; click to view 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, 2011. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.
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