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Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production - Couverture rigide
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
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Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production
Edité par
PDA/DHI Publishing, 2018
ISBN 10 : 1942911173
ISBN 13 : 9781942911173
Ancien ou d'occasion
Couverture rigide
Vendeur : Salish Sea Books, Bellingham, WA, Etats-Unis
Évaluation du vendeur 5 sur 5 étoiles
Etat : Very Good. Very Good++; Hardcover; Covers are still glossy; Unblemished textblock edges; The endpapers and all text pages are clean and unmarked; The binding is excellent with a straight spine; This book will be shipped in a sturdy cardboard box with foam padding; Medium Format (8.5" - 9.75" tall); 1.2 lbs; White covers with title in dark blue-green lettering; 2018, PDA/DHI Publishing; 525 pages; "Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production," by Trevor Deeks. N° de réf. du vendeur SKU-0595AR07710056
Acheter D'occasion
EUR 181,60
Expédition à EUR 4,45
Expédition nationale : Etats-Unis
Expédition nationale : Etats-Unis
Quantité disponible : 1 disponible(s)