Development and approval of combination products a regulatory perspective

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

Other author/creator	Siegel, Evan B.
Format	Electronic and Book
Publication Info	Hoboken, N.J. : Wiley,
Description	xii, 215 p. : ill. ; 25 cm.
Supplemental Content	Full text available from Ebook Central - Academic Complete
Subject(s)	United States. Food and Drug Administration. United States. Food and Drug Administration. 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.

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.
Bibliography note	Includes bibliographical references and index.
Access restriction	Available only to authorized users.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2008001360
ISBN	9780470050941 (hbk.)

Library	Location	Call Number	Status	Item Actions
	Electronic Resources	Access Content Online	✔ Available