The Challenge of CMC Regulatory Compliance for Biopharmaceuticals [Kindle Edition] Author: John Geigert | Language: English | ISBN:
B00COFW27S | Format: PDF, EPUB
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Download electronic versions of selected books The Challenge of CMC Regulatory Compliance for Biopharmaceuticals for everyone book 4shared, mediafire, hotfile, and mirror link 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.) Download latest books on mediafire and other links compilation The Challenge of CMC Regulatory Compliance for Biopharmaceuticals [Kindle Edition]
- File Size: 1858 KB
- Print Length: 338 pages
- Publisher: Springer New York; 2 edition (July 22, 2013)
- Sold by: Amazon Digital Services, Inc.
- Language: English
- ASIN: B00COFW27S
- Text-to-Speech: Enabled
X-Ray:
- Lending: Not Enabled
- Amazon Best Sellers Rank: #1,021,125 Paid in Kindle Store (See Top 100 Paid in Kindle Store)
There are precious few texts of this type, and Geigert wrote a previous edition about ten years ago, so this is a worthy update. It is not light reading but if one is at all involved in the development and bringing to market of modern biopharmaceuticals, then this text will definitely help them to be more successful than otherwise. It provides a wealth of useful, up-to-date information in all the areas of importance in preparing CMCs and meeting regulatory requirements, specifically for biopharmas. It was time well spent.
By Ira Krull
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Download
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