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

Like New Condition.Crisp pages. Clean cover and pages. Book shows no shelf wear. Not Satisfied? Contact us to get a refund.

Bestandsnummer des Verkäufers BRG-22_1_430

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: Like New
• Gewicht: 32 Unzen

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.