Development and approval of combination products
Subtitle: a regulatory perspective
By: [edited by] Evan B. Siegel.
Contributors: Siegel, Evan B.
Publisher: John Wiley
Published: 2008
Place of publication: Hoboken, N.J
Language: eng
ISBN-13: 9780470050941
Subjects: 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
Notes: Includes bibliographical references and index.
Table of contents: title: Overview of combination products development and regulatory review / Evan B. Siegel; title: Detailed regulatory approaches to development, review, and approval / James Barquest; title: Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings; title: Clinical pharmacology and clinical development of combination products / Chaline Brown; title: Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier.