Toxicologic pathology

01 15 October 2026

DOI 10.1177/01926233261475980

Scientific and Regulatory Policy Committee Points to Consider: Virtual Control Groups and Their Implications for Anatomic and Clinical Pathology Evaluation During Nonclinical Toxicity Studies

Open DOI

Kirstin Barnhart, Brad Bolon, Laura Boone et al.

Replacement of concurrent control groups (CCG) with virtual control groups (VCG) has been advocated as a strategy to reduce animal use in nonclinical toxicity testing. This “Points to Consider” paper examines VCG utility as it impacts to...

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02 15 October 2026

DOI 10.1177/01926233261476004

The Critical Role of Pathologists in Determining Scientifically Justified Applications for Virtual Control Groups in Toxicity Studies

Open DOI

Renee R Hukkanen, Kirstin Barnhart, Brad Bolon

03 29 September 2026

DOI 10.1177/01926233261485271

Characterization of Ketamine-Induced Neurotoxicity in PND7 Rats as a Model of Pediatric Anesthesia

Open DOI

S. Canesi, D. Bianchi, M. Longo et al.

Ketamine, a dissociative anesthetic commonly used in pediatric medicine, may induce neurotoxic effects when administered during early neonatal life. Although ketamine-induced neuronal apoptosis has been previously documented, less is kno...

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04 28 August 2026

DOI 10.1177/01926233261455350

Toxicologic Pathology Forum: ESTP/STP Working Group Opinion on the Evolving Landscape of New Approach Methodologies in Drug and Chemical Safety Development

Open DOI

Nadine Stokar-Regenscheit, Brian Berridge, Julia Kühnlenz et al.

In April 2025, the US Food and Drug Administration (FDA) introduced a bold roadmap to phase out animal testing in drug development by promoting the integration of New Approach Methodologies (NAMs), beginning with monoclonal antibodies (m...

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05 22 August 2026

DOI 10.1177/01926233261469528

Immunohistochemical Characterization of Intraocular Inflammation After Intravitreal Administration of Biologics to NHP and Minipigs: A Study Across Compounds

Open DOI

Theresa C. Brömel, Barbara Lenz, Rachel Neff et al.

Intraocular inflammation (IOI) following intravitreal (IVT) administration of large molecules (LM) is commonly seen in preclinical species and often relates to the presence of systemic anti-drug antibodies (ADA) as a reaction to the appl...

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06 20 August 2026

DOI 10.1177/01926233261456713

Deciphering Taste Disorders: Mechanistic Insights and Nonclinical Evaluation

Open DOI

Smitha P. S. Pillai, Keith Mansfield, Ricardo de Miguel et al.

Drug-induced taste dysfunctions are an underrecognized yet clinically significant class of adverse effects that can substantially impair patients’ quality of life and compromise adherence to therapeutic regimens. Despite the potential fo...

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07 18 August 2026

DOI 10.1177/01926233261475696

Unsupervised Single-Class Anomaly Detection in Rat Liver Using a Model of Normal Histomorphology

Open DOI

Thomas Forest, Raghav Amaravadi, Richard Baumgartner et al.

An unsupervised, single-class anomaly detection approach based on a vision transformer architecture was developed to aid histopathology evaluation of rat liver from nonclinical toxicology studies. The approach was designed to detect any ...

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08 12 August 2026

DOI 10.1177/01926233261471443

Spontaneous Mononuclear Cell Infiltrates and Inflammation in the Brain and Spinal Cord of Rodent and Nonrodent Laboratory Species

Open DOI

Antonia Morey-Matamalas, Davide Corbetta, Agnieszka Barc et al.

Mononuclear cell infiltrates (MCIs) and inflammation in the central nervous system (CNS) can be challenging in nonclinical studies, particularly in nonrodent species. A retrospective study was performed to determine the incidences of spo...

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09 12 August 2026

DOI 10.1177/01926233261465410

Cadmium Toxicity in Testis Organoids: Validation of an In Vitro Model for Testicular Toxicology

Open DOI

Tat-Chuan Cham, Fahar Ibtisham, Luis Antonio Rico Guerrero et al.

Environmental toxicants are increasingly implicated in male reproductive disorders, highlighting the need for physiologically relevant in vitro testicular models for toxicological testing. We previously developed a testis organoid system...

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10 11 August 2026

DOI 10.1177/01926233261462505

Toxicologic Evaluation of RC-0315, a Mesenchymal Stem Cell-Derived Secretome, Following Repeated Intratracheal Administration in Mice

Open DOI

Yuval Ramot, Michal Steiner, Noam Kronfeld et al.

RC-0315 is a chemotherapy-exposed mesenchymal stem cell-derived secretome developed as a potential advanced therapy for idiopathic pulmonary fibrosis (IPF). A Good Laboratory Practice (GLP)-compliant repeated-dose toxicity study was cond...

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