Overview

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.

Full Product Details

Author:   Sarfaraz K. Niazi
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Dimensions:   Width: 17.80cm , Height: 3.60cm , Length: 25.40cm
Weight:   1.179kg
ISBN:  

9780849329913

ISBN 10:   0849329914
Pages:   584
Publication Date:   15 August 2002
Audience:   Professional and scholarly ,  Professional and scholarly ,  Professional & Vocational ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

Introduction. Market Opportunities in Biogeneric Therapeutic Proteins. Scientific Issues in Therapeutic Protein Manufacturing. Overview of Therapeutic Protein Manufacturing. Development and Manufacturing of Recombinant DNA Therapeutic Proteins. Development and Manufacturing of Monoclonal Therapeutic Proteins. Regulatory Issues in Therapeutic Protein Filings. Analytical Issues in the Testing of Therapeutic Proteins. Intellectual Property Issues in Developing and Marketing Biogeneric Therapeutic Proteins. Preclinical Development of Therapeutic Proteins. Clinical Evaluation of Therapeutic Proteins. Glossary.

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Niazi, Sarfaraz K.

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