Biosimilar Drug Product Development

Herausgeber: Chow, Shein-Chung; Endrenyi, Laszlo; Declerck, Paul

• Gebundenes Buch

Produktbeschreibung

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 496
• Erscheinungstermin: 7. März 2017
• Englisch
• Abmessung: 240mm x 161mm x 31mm
• Gewicht: 906g
• ISBN-13: 9781498718790
• ISBN-10: 1498718795
• Artikelnr.: 47959877

Autorenporträt

Laszlo Endrenyi, Professor Emeritus, University of Toronto

Inhaltsangabe

Analytical characterization. Immunogenicity. Animal studies. Clinical
development. Manufacturing, process control. Extrapolation of indications.
Interchangeability, substitution. Pharmacovigilance. Statistical issues.
Regulatory issues.