1st Edition
Biosimilar Drug Product Development
496 Pages
14 Color & 31 B/W Illustrations
by
CRC Press
496 Pages
14 Color & 31 B/W Illustrations
by
CRC Press
496 Pages
14 Color & 31 B/W Illustrations
by
CRC Press
Also available as eBook on:
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... Read more
Analytical characterization. Immunogenicity. Animal studies. Clinical development. Manufacturing, process control. Extrapolation of indications. Interchangeability, substitution. Pharmacovigilance. Statistical issues. Regulatory issues.
Biography
Laszlo Endrenyi, Professor Emeritus, University of Toronto
