Biosimilar Drug Product Development

ISBN-13: 9780367552497 / Angielski / Miękka / 2020 / 496 str.

Laszlo Endrenyi (University of Toronto;. Paul Declerck;Shein-Chung Chow (Duke University School

Opis

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.

Spis treści

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

O autorze

Laszlo Endrenyi, Professor Emeritus, University of Toronto