Biosimilar Drug Product Development

Laszlo Endrenyi, Shein-Chung Chow, . Paul Declerck (Herausgeber)

Buch | Softcover

496 Seiten

2020
CRC Press (Verlag)
978-0-367-55249-7 (ISBN)

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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.

Laszlo Endrenyi, Professor Emeritus, University of Toronto

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

Erscheinungsdatum	01.07.2020
Reihe/Serie	Drugs and the Pharmaceutical Sciences
Zusatzinfo	24 Tables, black and white; 6 Line drawings, color; 26 Line drawings, black and white; 8 Halftones, color; 5 Halftones, black and white; 14 Illustrations, color; 31 Illustrations, black and white
Verlagsort	London
Sprache	englisch
Maße	156 x 234 mm
Gewicht	712 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Naturwissenschaften ► Biologie
	Technik
ISBN-10	0-367-55249-3 / 0367552493
ISBN-13	978-0-367-55249-7 / 9780367552497
Zustand	Neuware