Handbook of Analytical Validation - Couverture rigide

Swartz, Michael E.; Krull, Ira S.

Couverture rigide

ISBN 10 : 0824706897 ISBN 13 : 9780824706890

Editeur : CRC Press Inc, 2012

Synopsis

Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:

• Contains practical, up-to-date guidelines for analytical method validation
• Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications
• Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment

Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.

A propos du livre

À propos de l?auteur

Michael E. Swartz, Ira S. Krull

Détails de l'édition

• Éditeur: CRC Press Inc
• Date d'édition: 2012
• Langue: anglais
• ISBN 10: 0824706897
• ISBN 13: 9780824706890
• Reliure: Relié
• Nombre de pages: 206
• Coordonnées du fabricant: Easy Access System Europe Oü, 16879218; gpsr.requests@easproject.com; ; Mustamäe tee 50, 10621, Tallinn, Estonia; Tallinn; 10621; Estonie