Biosimilar Drug Product Development

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

Buch | Hardcover

496 Seiten

2017
Crc Press Inc (Verlag)
978-1-4987-1879-0 (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	07.06.2017
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	Bosa Roca
Sprache	englisch
Maße	156 x 234 mm
Gewicht	904 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Medizin / Pharmazie ► Pflege
	Medizin / Pharmazie ► Pharmazie
	Naturwissenschaften ► Biologie
	Technik ► Umwelttechnik / Biotechnologie
ISBN-10	1-4987-1879-5 / 1498718795
ISBN-13	978-1-4987-1879-0 / 9781498718790
Zustand	Neuware