The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (Hardcover, 2004 ed.)

"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed."

General

Imprint:	Kluwer Academic / Plenum Publishers
Country of origin:	United States
Release date:	December 2003
First published:	2004
Authors:	John Geigert
Dimensions:	254 x 178 x 25mm (L x W x T)
Format:	Hardcover
Pages:	350
Edition:	2004 ed.
ISBN-13:	978-0-306-48040-9
Categories:	Books > Law > Laws of other jurisdictions & general law > Social law > Public health & safety law Promotions
LSN:	0-306-48040-9
Barcode:	9780306480409

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