TY  - BOOK
AU  - Siegel,Evan B.
ED  - ebrary, Inc.
TI  - Development and approval of combination products: a regulatory perspective 
AV  - RA401.5 .D48 2008eb
U1  - 363.19/46 22
PY  - 2008///
CY  - Hoboken, N.J.
PB  - Wiley
KW  - United States
KW  - Food and Drug Administration
KW  - Drug approval
KW  - Biological products
KW  - Medical instruments and apparatus
KW  - Electronic books
KW  - local
N1  - 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; Electronic reproduction; Palo Alto, Calif.; ebrary; 2013; Available via World Wide Web; Access may be limited to ebrary affiliated libraries
UR  - http://site.ebrary.com/lib/strathmore/Doc?id=10296672
ER  -