Sarfaraz K Niazi

Handbook of Biogeneric Therapeutic Proteins

Regulatory, Manufacturing, Testing, and Patent Issues

• Broschiertes Buch

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

Produktdetails

• Verlag: Taylor & Francis Ltd (Sales)
• Seitenzahl: 584
• Erscheinungstermin: 9. Dezember 2019
• Englisch
• Abmessung: 254mm x 178mm x 30mm
• Gewicht: 1002g
• ISBN-13: 9780367454814
• ISBN-10: 0367454815
• Artikelnr.: 58438135

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.