Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow
February 17, 2017
by CRC Press
Reference - 477 Pages - 14 Color & 31 B/W Illustrations
ISBN 9781498718790 - CAT# K25468
Series: Drugs and the Pharmaceutical Sciences
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.
Analytical characterization. Immunogenicity. Animal studies. Clinical development. Manufacturing, process control. Extrapolation of indications. Interchangeability, substitution. Pharmacovigilance. Statistical issues. Regulatory issues.