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Toxicologic Pathology Forum Opinion: Rational Approaches to Expanded Neurohistopathology Evaluation for Nonclinical General Toxicity Studies and Juvenile Animal Studies

期刊: TOXICOLOGIC PATHOLOGY, 2023; 51 (6)

Existing nervous system sampling and processing best practices for nonclinical general toxicity studies (GTS) were designed to assess test articles wi......

Historical Control Background Incidence of Spontaneous Neoplastic Lesions of Sprague-Dawley Rats in 104-Week Toxicity Studies

期刊: TOXICOLOGIC PATHOLOGY, 2023; 51 (6)

Data collected from approximately 1800 male and 1800 female Sprague-Dawley (SD) rats used in 104-week carcinogenicity studies were archived in a histo......

Neurofilament Light Chain: A Translational Safety Biomarker for Drug-Induced Peripheral Neurotoxicity

期刊: TOXICOLOGIC PATHOLOGY, 2023; 51 (3)

Branaplam is a splicing modulator previously under development as a therapeutic agent for Spinal Muscular Atrophy Type 1 and Huntington's disease. Bra......

Toxicologic Pathology Forum: Opinion on Approaches for Reporting Toxic and Adverse Dose Levels in Nonclinical Toxicology Studies Supporting the Development of Anticancer Pharmaceuticals

期刊: TOXICOLOGIC PATHOLOGY, 2023; 51 (1-2)

The advancement of an investigational new drug in humans is a significant developmental milestone. In first-in-human (FIH)-enabling toxicology studies......

Assessment of Mouse Liver Histopathology Following Exposure to HFPO-DA With Emphasis on Understanding Mechanisms of Hepatocellular Death

期刊: TOXICOLOGIC PATHOLOGY, 2023; 51 (1-2)

Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)-propanoate (HFPO-DA) is a short chain member of per- and polyfluoroalkyl substances (PFAS). To bet......

Pathological Characterization of Spontaneous AA Amyloidosis in Microminipigs

期刊: TOXICOLOGIC PATHOLOGY, 2023; 51 (5)

The minipig has been used as a non-rodent species in nonclinical toxicology studies, but little is known about amyloid A (AA) amyloidosis in this spec......

Hepatic Bile Acid Transporters and Drug-induced Hepatotoxicity

期刊: TOXICOLOGIC PATHOLOGY, 2023; ()

Drug-induced liver injury (DILI) remains a major concern in drug development from a patient safety perspective because it is the leading cause of acut......

Chronic Inhalation Exposure to Antimony Trioxide Exacerbates the MAPK Signaling in Alveolar Bronchiolar Carcinomas in B6C3F1/N Mice

期刊: TOXICOLOGIC PATHOLOGY, 2023; 51 (1-2)

Antimony trioxide (AT) is used as a flame retardant in fabrics and plastics. Occupational exposure in miners and smelters is mainly through inhalation......

Toxicologic Pathology Forum: Opinion on Performing Good Laboratory Practice Histopathology Evaluation for Nonclinical Toxicity Studies in a Remote Location

期刊: TOXICOLOGIC PATHOLOGY, 2023; 51 (3)

Toxicologic/veterinary pathologists are working remotely from Good Laboratory Practice (GLP) test facilities (TFs) in increasing numbers, most commonl......

An Overview of Nonclinical and Clinical Liver Toxicity Associated With AAV Gene Therapy

期刊: TOXICOLOGIC PATHOLOGY, 2023; ()

This article reviews the presentation given at the 2023 annual meeting of the Society of Toxicologic Pathology (STP) on liver toxicity observed with a......

Retinal and Systemic Toxicity of Vigabatrin Is Driven by the S-Enantiomer in the Long Evans Rat

期刊: TOXICOLOGIC PATHOLOGY, 2023; ()

In this study, we assessed the toxicity and toxicokinetics of racemic vigabatrin and its S- and R-enantiomers (vigabatrin consists of 50:50% of the tw......

Early-Onset Asymptomatic Polypoid Cystitis in Two Adolescent Male Beagle Dogs

期刊: TOXICOLOGIC PATHOLOGY, 2023; 51 (6)

This brief communication describes a rare spontaneous background lesion in the lower urinary tract of two male laboratory beagles. Proliferative lesio......

Assessment of Color Reproducibility and Mitigation of Color Variation in Whole Slide Image Scanners for Toxicologic Pathology

期刊: TOXICOLOGIC PATHOLOGY, 2023; 51 (6)

Digital pathology workflows in toxicologic pathology rely on whole slide images (WSIs) from histopathology slides. Inconsistent color reproduction by ......

Can Historical Control Group Data Be Used to Replace Concurrent Controls in Animal Studies?

期刊: TOXICOLOGIC PATHOLOGY, 2023; 51 (6)

The availability of large amounts of high-quality control data from tightly controlled regulated animal safety data has created the idea to re-use the......

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