Handbook of Analytical Validation - Couverture rigide

Swartz, Michael E; Krull, Ira S

Couverture rigide

ISBN 10 : 1498715079 ISBN 13 : 9781498715072

Editeur : Productivity Press, 2014

Synopsis

Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, it contains practical, up-to-date guidelines for analytical method validation. It also 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 the biotech industry.

Détails de l'édition

• Éditeur: Productivity Press
• Date d'édition: 2014
• Langue: anglais
• ISBN 10: 1498715079
• ISBN 13: 9781498715072
• Reliure: Relié
• Nombre de pages: 226
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible