Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production - Couverture rigide

Trevor Deeks

 
9781942911173: Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production
Couverture rigide
ISBN 10 : 1942911173 ISBN 13 : 9781942911173
Editeur : PDA/DHI, 2018

Synopsis

This book provides succinct and practical guidance on how to develop a biological drug product and, at the same time, stay within the regulatory expectations at each phase of the development process! Within this book, you can find chapters on: ~ Current manufacturing and process development of Regenerative Medicine Advanced Therapy Products (RMATs), or as they are known in the EU, Advanced Therapy Medicinal Products (ATMPs) ~ Quality systems and GMP requirements for Phase 1 to Phase 3 manufacturing ~ The impact of the Clinical Trials Directive on European GMP expectations and the role of the QP ~ The latest USP guidance on the transfer of analytical methods, validation and verification of compendial procedures ~ And, much more

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Éditeur
PDA/DHI
Date d'édition
2018
Langue
anglais
ISBN 10 
1942911173
ISBN 13 
9781942911173
Reliure
Hardcover
Nombre de pages
525
Éditeur
Trevor Deeks
Coordonnées du fabricant
non disponible
Personne responsable
non disponible