Carcinogenicity of Biopharmaceuticals
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Publication date
2015
Authors
Dempster, M
Siezen, CLE
ter Braak, SJ
van den Brink, WJ
Emerenciana, A
Bellanti, F
Duijnhoven, R.G.
Kwa, SG
van der Laan, JW
Editors
Graziano, M
Jacobson-Kram, D
Advisors
Supervisors
Document Type
Part of book
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taverne
Abstract
This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests.
Keywords
Carcinogenicity evaluation, Biotechnology-derived pharmaceuticals, Non-clinical evaluation, Insulin, GLP-1 agonists, Immunomodulators, Taverne
Citation
Dempster, M, Siezen, CLE, ter Braak, SJ, van den Brink, WJ, Emerenciana, A, Bellanti, F, Duijnhoven, R G, Kwa, SG & van der Laan, JW 2015, Carcinogenicity of Biopharmaceuticals. in M Graziano & D Jacobson-Kram (eds), Genotoxicity and Carcinogenicity Testing of Pharmaceuticals. Springer, Cham, pp. 125-157. https://doi.org/10.1007/978-3-319-22084-0_8