Author: John Geigert
Edition: 2004
Publisher: Springer
Binding: Hardcover
ISBN: 0306480409
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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. Medical books The Challenge of CMC Regulatory Compliance for Biopharmaceuticals. Medical books The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals John Geigert. author john geigert format hardback language english publication year 01 12 2003 subject law subject 2 national law professional title the challenge of cmc regulatory compliance for biopharmaceuticals author john geigert publisher plenum pub corp publication date feb 01 2004 pages 350 binding hardcover edition 1 st dimensions 6 75 wx 9 75 hx 1 00 d isbn 0306480409 subject medical pharmacology brand new hardcover all orders get full access to our online status tracking service allowing you to v
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author john geigert format hardback language english publication year 01 12 2003 subject law subject 2 national law professional title the challenge of cmc regulatory compliance for biopharmaceuticals author john geigert publisher plenum pub corp publication date feb 01 2004 pages 350 binding hardcover edition 1 st dimensions 6 75 wx 9 75 hx 1 00 d isbn 0306480409 subject medical pharmacology brand new hardcover all orders get full access to our online status tracking service allowing you to v
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 b
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.
"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.File Size: 4086 KBPrint Length: 386 pagesPublisher: Springer; 1 edition (December 31, 2003) Sold by: Amazon Digital Services, Inc.Language: EnglishASIN: B001P05GXU"
Medical Book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval.
