Endrenyi / Declerck / Chow Biosimilar Drug Product Development

1. Auflage 2017
ISBN: 978-1-4987-1880-6
Verlag: CRC Press
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 496 Seiten

Reihe: 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.

Autoren/Hrsg.

Endrenyi, Laszlo

Declerck, Dr. Paul

Declerck, Paul

Chow, Shein-Chung

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie

Inhaltsverzeichnis

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