Sarfaraz K. Niazi

Handbook of Biogeneric Therapeutic Proteins (eBook, PDF)

Regulatory, Manufacturing, Testing, and Patent Issues

• Format: PDF

Produktbeschreibung

Handbook of Biogeneric Therapeutic Proteins is the first book to offer extensive coverage of all aspects of generic and 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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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 584
• Erscheinungstermin: 15. August 2002
• Englisch
• ISBN-13: 9781420037937
• Artikelnr.: 52936901

Autorenporträt

Niazi, Sarfaraz K.

Inhaltsangabe

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.