Table of Contents: Development and approval of combination products

Corporate Author:	ebrary, Inc.
Other Authors:	Siegel, Evan B.
Format:	Book
Language:	English
Published:	Hoboken, N.J. : Wiley, c2008.
Subjects:	Drug approval > United States. Biological products > United States. Medical instruments and apparatus > United States.
Online Access:	http://site.ebrary.com/lib/ucy/Doc?id=10296672

Table of 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.