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

Contributor(s): Publication details: Hoboken, N.J. : Wiley, c2008.Description: xii, 215 p. : ill. ; 25 cmSubject(s): Genre/Form: DDC classification:
  • 363.19/46 22
LOC classification:
  • RA401.5 .D48 2008eb
Online resources:
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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E-Book Taylor's Library-TU 363.19/46 (Browse shelf(Opens below)) e-book

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.

TSLHHL

Electronic reproduction. Palo Alto, Calif. : ebrary, 2009. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.