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£172.90
Springer The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Price data last checked 56 day(s) ago - refreshing...
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Last 35 days • 35 data points (No recent data available)
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Price distribution over 35 days • 2 price levels
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Most common price: £175 (34 days, 97.1%)
Price range: £173 - £175
Price levels: 2 different prices over 35 days
Description
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.)
Product Specifications
- Brand
- Springer
- Format
- Hardcover
- ASIN
- 1461469155
- Domain
- Amazon UK
- Release Date
- 07 May 2013
- Listed Since
- 02 February 2013
Barcode
No barcode data available
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