Artículos relacionados a Biologics Development: Regulatory Overview

Biologics Development: Regulatory Overview - Tapa dura

 
9781882615674: Biologics Development: Regulatory Overview
Tapa dura
ISBN 10: 1882615670 ISBN 13: 9781882615674
Editorial: Barnett Educational Services / Chi, 2004

Sinopsis

Book by Mark P Mathieu Mark Mathieu Mathieu Mark P

"Sinopsis" puede pertenecer a otra edición de este libro.

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.

"Sobre este título" puede pertenecer a otra edición de este libro.

Editorial
Barnett Educational Services / Chi
Año de publicación
2004
Idioma
Inglés
ISBN 10 
1882615670
ISBN 13 
9781882615674
Encuadernación
Tapa dura
Número de edición
3
Número de páginas
300
Editor
Mathieu Mark P.
Contacto del fabricante
no disponible
Persona responsable
no disponible