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Development and approval of combination products : a regulatory perspective / edited by Evan B. Siegel. - Hoboken, N.J. : Wiley, 2008. - xii, 215 p. : ill. ; 25 cm.

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.

ISBN: 9780470050941 (hbk.)

Subjects--Corporate Names:
United States. Food and Drug Administration.

Subjects--Topical Terms:
Drug approval--United States.
Biological products--United States.
Medical instruments and apparatus--United States.
Drug Approval--legislation & jurisprudence--United States.
Drug Combinations--United States.
Device Approval--legislation & jurisprudence--United States.

Dewey Class. No.: 363.1946 / D487