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Handbook of Biogeneric Therapeutic Proteins

Handbook of Biogeneric Therapeutic Proteins

Regulatory, Manufacturing, Testing, and Patent Issues

by Sarfaraz K. Niazi
Hardback
Publication Date: 15/08/2002

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Handbook of Biogeneric Therapeutic Proteins is the first book to offer extensive coverage of all aspects of generic 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. The handbook 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.
ISBN:
9780849329913
9780849329913
Category:
Biology
Format:
Hardback
Publication Date:
15-08-2002
Language:
English
Publisher:
Taylor & Francis Inc
Country of origin:
United States
Pages:
584
Dimensions (mm):
254x178x36mm
Weight:
1.18kg

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