Development and approval of combination products a regulatory perspective

Bibliographic Details
Other Authors:	Siegel, Evan B. (-)
Format:	eBook
Language:	Inglés
Published:	Hoboken, N.J. : Wiley c2008.
Subjects:	United States. > Food and Drug Administration. Drug approval > United States. Biological products > United States. Medical instruments and apparatus > United States. Electronic books.
Online Access:	https://recursos.uloyola.es/login?url=https://accedys.uloyola.es:8443/accedix0/sitios/ebook.php?id=177758
See on Universidad Loyola - Universidad Loyola Granada:	https://colectivo.uloyola.es/Record/ELB177758

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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.

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