Developing a pragmatic consensus procedure supporting the ICH S1B(R1) weight of evidence carcinogenicity assessment

Developing a pragmatic consensus procedure supporting the ICH S1B(R1) weight of evidence carcinogenicity assessment

The ICH S1B carcinogenicity global testing guideline has been recently revised with a novel addendum that describes a comprehensive integrated Weight of Evidence (WoE) approach to determine the need for a 2-year rat carcinogenicity study. In the present work, experts from different organizations hav...

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Bibliographic Details
Main Authors: Arianna Bassan, Ronald Steigerwalt, Douglas Keller, Lisa Beilke, Paul M. Bradley, Frank Bringezu, William J. Brock, Leigh Ann Burns-Naas, Jon Chambers, Kevin Cross, Michael Dorato, Rosalie Elespuru, Douglas Fuhrer, Frances Hall, Jim Hartke, Gloria D. Jahnke, Felix M. Kluxen, Eric McDuffie, Friedemann Schmidt, Jean-Pierre Valentin, David Woolley, Doris Zane, Glenn J. Myatt
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-04-01
Series:Frontiers in Toxicology
Subjects:
carcinogenicity assessment
WoE
ICHS1B
2-year rat bioassay
integrated assessment
pharmaceuticals
Online Access:https://www.frontiersin.org/articles/10.3389/ftox.2024.1370045/full

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