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Biosimilar Drug Product Development de Laszlo Endrenyi

Biosimilar Drug Product Development: Drugs and the Pharmaceutical Sciences

Editat de Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow
en Limba Engleză Hardback – 7 mar 2017
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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Specificații

ISBN-13: 9781498718790
ISBN-10: 1498718795
Pagini: 496
Ilustrații: 90
Dimensiuni: 156 x 234 x 32 mm
Greutate: 0.9 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
Seria Drugs and the Pharmaceutical Sciences

Public țintă

Academic and Professional Practice & Development

Cuprins

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

Descriere

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.