Sarfaraz K. Niazi

Handbook of Biogeneric Therapeutic Proteins (eBook, ePUB)

Regulatory, Manufacturing, Testing, and Patent Issues

• Format: ePub

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: 9781000611328
• Artikelnr.: 57001547

Autorenporträt

Professor Sarfaraz K. Niazi is the chief executive officer of Pharmaceutical Scientist Inc., a consulting company for the pharmaceutical and biotechnology industry (http://www.pharmsci.com). He is also Foreign Professor at the HEJ Research Institute of Chemistry at Karachi University in Pakistan. Professor Niazi has been involved in the licensing, technology transfer, process development, and turnkey pharmaceutical and therapeutic protein manufacturing operations worldwide. Professor Niazi is also licensed to practice patent law before the U.S. Patent and Trademark office and an inventor with scores of patents on new drugs and drug delivery systems. Professor Niazi has been teaching and conducting research for over 35 years and has authored over 100 research articles and written scores of books in the field of pharmaceutical and biotechnology manufacturing, pharmacokinetics, literature, and poetry. His most recent book, Handbook of Pharmaceutical Manufacturing Formulations , is a six-volume work, the largest of its kind ever published. Professor Niazi lives in Deerfield, Illinois, and Karachi, Pakistan.

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.