1st Edition

Biosimilar Drug Product Development





ISBN 9781498718790
Published March 7, 2017 by CRC Press
487 Pages 14 Color & 31 B/W Illustrations

USD $200.00

Prices & shipping based on shipping country


Preview

Book Description

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.

Table of Contents

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

...
View More

Editor(s)

Biography

Laszlo Endrenyi, Professor Emeritus, University of Toronto