The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Second Edition 2013
by
John Geigert
Book Details
Format
Paperback / Softback
ISBN-10
1493943995
ISBN-13
9781493943999
Edition
Second Edition 2013
Publisher
Springer-Verlag New York Inc.
Imprint
Springer-Verlag New York Inc.
Country of Manufacture
US
Country of Publication
GB
Publication Date
Aug 23rd, 2016
Print length
338 Pages
Weight
684 grams
Dimensions
17.90 x 25.30 x 2.50 cms
Product Classification:
Medical researchPre-clinical medicine: basic sciencesChemistry
Ksh 28,800.00
Werezi Extended Catalogue
0 in stock
Delivery Location
Delivery fee: Select location
Secure
Quality
Fast
This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing.
This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
Get The Challenge of CMC Regulatory Compliance for Biopharmaceuticals by at the best price and quality guaranteed only at Werezi Africa's largest book ecommerce store. The book was published by Springer-Verlag New York Inc. and it has pages.
