Development and approval of combination products a regulatory perspective /

Enregistré dans:

Détails bibliographiques
Collectivité auteur:	ebrary, Inc
Autres auteurs:	Siegel, Evan B.
Format:	Électronique eBook
Langue:	anglais
Publié:	Hoboken, N.J. : Wiley, c2008.
Sujets:	United States. > Food and Drug Administration. Drug approval > United States. Biological products > United States. Medical instruments and apparatus > United States. Electronic books.
Accès en ligne:	An electronic book accessible through the World Wide Web; click to view
Tags:	Ajouter un tag Pas de tags, Soyez le premier à ajouter un tag!

Table des matières:

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.

Documents similaires