ICH S1 prospective evaluation study: weight of evidence approach to predict outcome and value of 2-year rat carcinogenicity studies. A report from the regulatory authorities subgroup

ICH S1 prospective evaluation study: weight of evidence approach to predict outcome and value of 2-year rat carcinogenicity studies. A report from the regulatory authorities subgroup

Introduction: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) initiated a process in 2012 to revise the S1B Guideline “Testing for Carcinogenicity of Pharmaceuticals”. Previous retrospective analysis indicated the importance of histopatho...

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Bibliographic Details
Main Authors: Todd Bourcier, Timothy McGovern, Tania Cavaliero, Geoffrey Ebere, Akiyoshi Nishikawa, Jihei Nishimura, Kumiko Ogawa, Markku Pasanen, Alisa Vespa, Jan Willem Van der Laan
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-04-01
Series:Frontiers in Toxicology
Subjects:
carcinogenicity
bioassay
weight of evidence
ICH S1B(R1)
risk assessment
pharmaceuticals
Online Access:https://www.frontiersin.org/articles/10.3389/ftox.2024.1353783/full

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https://www.frontiersin.org/articles/10.3389/ftox.2024.1353783/full

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