Development and approval of combination products
Development and approval of combination products a regulatory perspective / [electronic resource] :
edited by Evan B. Siegel.
- Hoboken, N.J. : Wiley, c2008.
- 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.
Electronic reproduction.
Palo Alto, Calif. :
ebrary,
2009.
Available via World Wide Web.
Access may be limited to ebrary affiliated libraries.
DNLM
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.
Electronic books.
RA401.5 / .D48 2008eb
363.19/46
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,
2009.
Available via World Wide Web.
Access may be limited to ebrary affiliated libraries.
DNLM
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.
Electronic books.
RA401.5 / .D48 2008eb
363.19/46