Biosimilar Drug Product Development

1. Auflage 2017
ISBN: 978-1-4987-1879-0
Verlag: CRC Press

Buch, Englisch, 496 Seiten, Format (B × H): 161 mm x 240 mm, Gewicht: 904 g

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.

Zielgruppe

Academic and Professional Practice & Development

Autoren/Hrsg.

Endrenyi, Laszlo

Declerck, Paul

Chow, Shein-Chung

Declerck, Dr. Paul

Fachgebiete

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

Inhaltsverzeichnis

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