Biologics Development: A Regulatory Overview

Mark P. Mathieu; Mark Mathieu; Mathieu, Mark P.

ISBN 10: 1882615670 / ISBN 13: 9781882615674

Verlag: Barnett Educational Services / Chi, 2004

Beschreibung

The book is in good condition with all pages and cover intact, including the dust jacket if originally issued. The spine may show light wear. Pages may contain some notes or highlighting, and there might be a "From the library of" label. Boxed set packaging, shrink wrap, or included media like CDs may be missing.

Bestandsnummer des Verkäufers BSM.S0Z4

Bibliografische Details

• Titel: Biologics Development: A Regulatory Overview
• Verlag: Barnett Educational Services / Chi
• Erscheinungsjahr: 2004
• Sprache: Englisch
• ISBN-10: 1882615670
• ISBN-13: 9781882615674
• Einband: Hardcover
• Auflage: 3. Auflage
• Zustand: good

Über diesen Titel

Inhaltsangabe

Book by Mark P Mathieu Mark Mathieu Mathieu Mark P

Reseña del editor

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.