Scientific and Regulatory Policy Committee Points to Consider: Sample Selection, Assay Design, Data Generation and Interpretation, and Reporting Practices for Chromogenic Immunohistochemical (IHC) Assays in Nonclinical Drug Development

Famke Aeffner; Brad Bolon; Molly H Boyle; Bernard S Buetow; Thomas Forest; Kyathanahalli Janardhan; Keith Mansfield; David K Meyerholz; Shari Price; Marlon C Rebelatto

doi:10.1177/01926233251393154

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Scientific and Regulatory Policy Committee Points to Consider: Sample Selection, Assay Design, Data Generation and Interpretation, and Reporting Practices for Chromogenic Immunohistochemical (IHC) Assays in Nonclinical Drug Development

Journal article

Peer reviewed

Scientific and Regulatory Policy Committee Points to Consider: Sample Selection, Assay Design, Data Generation and Interpretation, and Reporting Practices for Chromogenic Immunohistochemical (IHC) Assays in Nonclinical Drug Development

Famke Aeffner, Brad Bolon, Molly H Boyle, Bernard S Buetow, Thomas Forest, Kyathanahalli Janardhan, Keith Mansfield, David K Meyerholz, Shari Price and Marlon C Rebelatto

Toxicologic pathology, Vol.54(3), pp.233-266

04/2026

DOI: 10.1177/01926233251393154

PMID: 41470013

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Abstract

Chromogenic immunohistochemistry (IHC) is an important molecular localization assay in biomedical research and nonclinical drug development, enabling the visualization of specific epitopes within tissues. The methodology is widely used in drug target selection, risk assessment, understanding disease biology, and characterizing histopathological findings in nonclinical studies. The Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathology formed a working group to compile essential information on chromogenic IHC assays not performed in compliance with Good Laboratory Practice (GLP) from nonclinical studies, using relevant literature and the Working Group members' collective expertise. In this "Points to Consider" article, emphasis is placed on factors influencing IHC data quality, including sample selection, general assay considerations, data generation and interpretation, and effective reporting. The Working Group members deliberated extensively on pertinent topics, aiming to provide specific and practical guidance for pathologists, histologists, and allied scientists engaged in chromogenic IHC assays. While refraining from an exhaustive exploration of the intricate technical details associated with chromogenic IHC, this article offers insights to enhance the accuracy, credibility, and reproducibility of chromogenic IHC, thereby facilitating informed decision-making in the nonclinical development of biomedical products.

Immunohistochemistry

Molecular Pathology

assay qualification

scoring paradigms

reproducibility

nonclinical development

assay optimization

chromogenic

Details

Title: Subtitle: Scientific and Regulatory Policy Committee Points to Consider: Sample Selection, Assay Design, Data Generation and Interpretation, and Reporting Practices for Chromogenic Immunohistochemical (IHC) Assays in Nonclinical Drug Development
Creators: Famke Aeffner - Amgen (United States)
Brad Bolon - NewPath Research
Molly H Boyle - Vencore (United States)
Bernard S Buetow - Pfizer (United States)
Thomas Forest - Merck & Co., Inc., Rahway, NJ, USA (United States)
Kyathanahalli Janardhan - Merck & Co., Inc., Rahway, NJ, USA (United States)
Keith Mansfield - Novartis (United States)
David K Meyerholz - University of Iowa
Shari Price - Charles River Laboratories (United States)
Marlon C Rebelatto - AstraZeneca (United States)
Resource Type: Journal article
Publication Details: Toxicologic pathology, Vol.54(3), pp.233-266
DOI: 10.1177/01926233251393154
PMID: 41470013
NLM abbreviation: Toxicol Pathol
ISSN: 1533-1601
eISSN: 1533-1601
Publisher: Sage
Language: English
Electronic publication date: 12/30/2025
Date published: 04/2026
Academic Unit: Pathology
Record Identifier: 9985113252402771

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