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

Contributor(s): Siegel, Evan B | ProQuest (Firm)Material type: TextTextPublication details: Hoboken, N.J. : Wiley, c2008Description: xii, 215 p. : illSubject(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 LOC classification: RA401.5 | .D48 2008Online resources: Click to View
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.
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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. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.

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