Biologics Development: Regulatory Overview - Hardcover

 
9781882615674: Biologics Development: Regulatory Overview
Hardcover
ISBN 10: 1882615670 ISBN 13: 9781882615674
Verlag: Barnett Educational Services / Chi, 2004

Inhaltsangabe

This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products.

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Verlag
Barnett Educational Services / Chi
Erscheinungsdatum
2004
Sprache
Englisch
ISBN 10 
1882615670
ISBN 13 
9781882615674
Einband
Gebundene Ausgabe
Auflage
3
Anzahl der Seiten
300
Herausgeber
Mathieu Mark P.
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
Nicht verfügbar