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

Arianna Bassan¹, Ronald Steigerwalt², Douglas Keller³, Lisa Beilke⁴, Paul M Bradley⁵, Frank Bringezu⁶, William J Brock⁷, Leigh Ann Burns-Naas⁸, Jon Chambers⁵, Kevin Cross⁹, Michael Dorato¹⁰, Rosalie Elespuru¹¹, Douglas Fuhrer¹², Frances Hall⁵, Jim Hartke¹³, Gloria D Jahnke¹⁴, Felix M Kluxen¹⁵, Eric McDuffie¹⁶, Friedemann Schmidt¹⁷, Jean-Pierre Valentin¹⁸, David Woolley¹⁹, Doris Zane¹³, Glenn J Myatt⁹

¹Innovatune srl, Padova, Italy.

²Takeda Development Center Americas, San Diego, CA, United States.

³Independent Consultant, Kennett Square, PA, United States.

⁴Toxicology Solutions, Inc., Marana, AZ, United States.

⁵Instem, Cambridge, United Kingdom.

⁶Chemical and Preclinical Safety, Merck Healthcare KGaA, Darmstadt, Germany.

⁷Brock Scientific Consulting, LLC, Hilton Head, SC, United States.

⁸Magnolia Toxicology Consulting, LLC, Traverse City, MI, United States.

⁹Instem, Conshohocken, PA, United States.

¹⁰MBX Biosciences, Carmel, IN, United States.

¹¹Independent Consultant, Annapolis, MD, United States.

¹²BioXcel Therapeutics, Inc., New Haven, CT, United States.

¹³Gilead Sciences, Inc., Foster City, CA, United States.

¹⁴Independent Consultant, Chapel Hill, NC, United States.

¹⁵ADAMA Deutschland GmbH, Cologne, Germany.

¹⁶Neurocrine Bioscience, Inc., San Diego, CA, United States.

¹⁷Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.

¹⁸UCB Biopharma SRL, Braine l'Alleud, Belgium.

¹⁹ForthTox Ltd., Linlithgow, United Kingdom.

PubMed PMC DOI PDF

Abstract

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 have joined efforts to standardize as much as possible a procedural framework for the integration of ev…

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