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Guide for Combining Primary Tumors for Statistical Analysis in Rodent Carcinogenicity Studies. 2024
Charlotte Keenan, and
Muthafar Al-Haddawi, and
Jean-Guy Bienvenu, and
Alys Elizabeth Bradley, and
Paul Brown, and
Hepei Chen, and
Karyn Colman, and
Michael Elwell, and
Nicholas Gatto, and
Dawn Goodman, and
Binod Jacob, and
Lynda Lanning, and
LuAnn McKinney, and
Erin Muhlbradt, and
Rick Perry, and
Alessandro Piaia, and
Daniel Potenta, and
Karen S Regan, and
Benjamin Sefing, and
Michael Thibodeau, and
Erin Tibbs-Slone, and
Jochen Woicke, and
Craig M Zwickl
C.M. Keenan ToxPath Consulting, Doylestown, Pennsylvania, USA.
The Tumor Combination Guide was created at the request of the U. S. Food and Drug Administration (FDA) by a Working Group of biopharmaceutical experts from international societies of toxicologic pathology, the Food and Drug Administration (FDA), and members of the Standard for Exchange of Nonclinical Data (SEND) initiative, to assist pharmacology/toxicology reviewers and biostatisticians in statistical analysis of nonclinical tumor data. The guide will also be useful to study and peer review pathologists in interpreting the tumor data. This guide provides a higher-level hierarchy of tumor types or categories correlating the tumor names from the International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) publications with those available in the NEOPLASM controlled terminology (CT) code list in SEND. The version of CT used in a study should be referenced in the nonclinical study data reviewer's guide (SDRG) (section 3.1) of electronic submissions to the FDA. The tumor combination guide instructions and examples are in a tabular format to make informed decisions for combining tumor data for statistical analysis. The strategy for combining tumor types for statistical analysis is based on scientific criteria gleaned from the current scientific literature; as SEND and INHAND terminology and information evolve, this guide will be updated.
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