Carcinogenicity of Biopharmaceuticals

M Dempster; CLE Siezen; SJ ter Braak; WJ van den Brink; A Emerenciana; F Bellanti; R.G. Duijnhoven; SG Kwa; JW van der Laan

doi:10.1007/978-3-319-22084-0_8

Carcinogenicity of Biopharmaceuticals

M Dempster, CLE Siezen, SJ ter Braak, WJ van den Brink, A Emerenciana, F Bellanti, R.G. Duijnhoven, SG Kwa, JW van der Laan

Pharmacoepidemiology and Clinical Pharmacology

Research output: Chapter in Book/Report/Conference proceeding › Chapter › Academic › peer-review

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.

Original language	English
Title of host publication	Genotoxicity and Carcinogenicity Testing of Pharmaceuticals
Editors	M Graziano, D Jacobson-Kram
Place of Publication	Cham
Publisher	Springer
Pages	125-157
ISBN (Electronic)	978-3-319-22084-0
ISBN (Print)	978-3-319-22083-3
DOIs	https://doi.org/10.1007/978-3-319-22084-0_8
Publication status	Published - 2015

Keywords

Carcinogenicity evaluation
Biotechnology-derived pharmaceuticals
Non-clinical evaluation
Insulin
GLP-1 agonists
Immunomodulators

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10.1007/978-3-319-22084-0_8

dempsterFinal published version, 572 KBLicence: Taverne

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keywords = "Carcinogenicity evaluation, Biotechnology-derived pharmaceuticals, Non-clinical evaluation, Insulin, GLP-1 agonists, Immunomodulators",

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AU - Dempster, M

AU - Siezen, CLE

AU - ter Braak, SJ

AU - van den Brink, WJ

AU - Emerenciana, A

AU - Bellanti, F

AU - Duijnhoven, R.G.

AU - Kwa, SG

AU - van der Laan, JW

PY - 2015

Y1 - 2015

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KW - Carcinogenicity evaluation

KW - Biotechnology-derived pharmaceuticals

KW - Non-clinical evaluation

KW - Insulin

KW - GLP-1 agonists

KW - Immunomodulators

U2 - 10.1007/978-3-319-22084-0_8

DO - 10.1007/978-3-319-22084-0_8

M3 - Chapter

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EP - 157

BT - Genotoxicity and Carcinogenicity Testing of Pharmaceuticals

A2 - Graziano, M

A2 - Jacobson-Kram, D

PB - Springer

CY - Cham

ER -

Carcinogenicity of Biopharmaceuticals

Abstract

Keywords

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