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Science/Engineering Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues

Posted on 2010-03-16




Name:Science/Engineering Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues
ASIN/ISBN:0849329914
Language:English
File size:4.2 Mb
Publisher: Informa Healthcare
ISBN: 0849329914
Publish Date: edition 2005
File Type: PDF
Pages: 584 pages
File Size: 4,2 mb
   Science/Engineering Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues



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Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues By Sarfaraz K. Niazi

Handbook of Biogeneric Therapeutic Proteins is the first book to offer extensive coverage of all aspects of generic or biosimilar biological products, from the scientific basis through the marketing issues. This practical book includes comprehensive information on establishing a manufacturing system and securing regulatory approval for biogeneric pharmaceutical products. It explains how to establish facilities to manufacture the raw materials used in biological products and how to prepare finished products. The author also provides details about the Chemistry, Manufacturing, and Controls (CMC) section of the FDA's New Drug Application for Biological Products.

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