Toxicologic Pathology最新文献

Toxicologic Pathology Forum: Opinion on Addressing Gaps in INHAND Terminology for Medical Devices-A Proposal to Add New Diagnostic Nomenclature.

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-04-05 DOI: 10.1177/01926233251331580

JoAnn C L Schuh, Lyn M Wancket, Brad Bolon, Kathleen A Funk, Nicole Kirchhof, Joanna M Rybicka

{"title":"Toxicologic Pathology Forum: Opinion on Addressing Gaps in INHAND Terminology for Medical Devices-A Proposal to Add New Diagnostic Nomenclature.","authors":"JoAnn C L Schuh, Lyn M Wancket, Brad Bolon, Kathleen A Funk, Nicole Kirchhof, Joanna M Rybicka","doi":"10.1177/01926233251331580","DOIUrl":"https://doi.org/10.1177/01926233251331580","url":null,"abstract":"Historically, safety and efficacy assessment of medical devices began and has continued as standards under the International Organization for Standardization (ISO) rather than under regulatory agency guidelines applied to developing other biomedical product classes. These parallel and unequal pathways have led to multiple and substantive differences in methods and endpoints to determine adverse biological responses among therapeutic classes. Toxicologic pathologists with medical device experience consider standardized nomenclature and diagnostic criteria for medical devices and device-containing combination products as a critical unmet need for nonclinical pathology evaluations. The International Harmonization of Nomenclature and Diagnostic Criteria for Lesions (INHAND) initiative has established globally accepted terminology for proliferative and nonproliferative lesions in various laboratory animal species. Experienced pathologists have identified that some existing INHAND terms for rodents and particularly nonrodents are already used or can be modified for use in medical device studies, but new terms for diagnostic features unique to medical device studies are needed to close gaps in existing INHAND nomenclature. The best approach to establishing appropriate INHAND terms for medical devices (and by extension, device-containing combination products) will be to develop and implement suitable terminology (modified and new, as warranted) to address unmet needs for this distinctive therapeutic class.","PeriodicalId":23113,"journal":{"name":"Toxicologic Pathology","volume":" ","pages":"1926233251331580"},"PeriodicalIF":1.4,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143789227","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Immunotoxicology From a Pathology Perspective: A Continuing Education Course Presented at the Annual STP Meeting in Baltimore, MD, Held June 16-19, 2024.

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-03-31 DOI: 10.1177/01926233251328970

Tracey L Papenfuss, Ashwini Phadnis Moghe, Lauren E Himmel, Ana Goyos, Daniel Weinstock

引用次数: 0

Toxicologic Pathology Forum*: Opinion on New Technologies and Trends Disrupting Drug Discovery and Development: How Can the Next Generation of Toxicologic Pathologists Be Prepared for Evolving Roles?

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-03-31 DOI: 10.1177/01926233251321805

Rebecca Kohnken, Lauren Himmel, Magali Guffroy, Eric A G Blomme

{"title":"Toxicologic Pathology Forum*: Opinion on New Technologies and Trends Disrupting Drug Discovery and Development: How Can the Next Generation of Toxicologic Pathologists Be Prepared for Evolving Roles?","authors":"Rebecca Kohnken, Lauren Himmel, Magali Guffroy, Eric A G Blomme","doi":"10.1177/01926233251321805","DOIUrl":"https://doi.org/10.1177/01926233251321805","url":null,"abstract":"The pace of technological innovation in the pharmaceutical industry, like in many other sectors, is accelerating rapidly. This is not only reshaping how pharmaceutical Research and Development (R&D) is conducted (e.g., introduction of novel models, endpoints, and instrumentation) but also influencing the types of therapeutic modalities being developed. In addition, societal and regulatory expectations have evolved to emphasize approaches that align with the 4Rs principles (Replacement, Reduction, Refinement, and Responsibility) and to encourage the replacement of animal testing with new approach methods (NAMs) through the FDA Modernization Act 2.0. While innovation, societal changes, and regulatory evolution are not new, what stands out is the unprecedented speed and scale at which these transformations are occurring. This acceleration is fueled predominantly by groundbreaking technological advancements (e.g., artificial intelligence, deep learning, communication tools, and digital pathology) in the context of rapidly changing societal dynamics such as globalization, social networking, and the increase in remote working. Given these potentially disruptive changes, it is essential to consider how toxicologic pathologists need to adapt. More importantly, how can they leverage these advancements to contribute even more significantly to the discovery and development of novel, safe, and effective medicines? In essence, what types of toxicologic pathologists will the pharmaceutical industry require in the future?","PeriodicalId":23113,"journal":{"name":"Toxicologic Pathology","volume":" ","pages":"1926233251321805"},"PeriodicalIF":1.4,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143754580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Interpretative Challenges in Animal Studies: Review of Case Studies and Implications for Toxicologic Pathology.

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-03-28 DOI: 10.1177/01926233251322767

Ruba Ibrahim, Abraham Nyska, Susan A Elmore, Molly Boyle, Yuval Ramot

{"title":"Interpretative Challenges in Animal Studies: Review of Case Studies and Implications for Toxicologic Pathology.","authors":"Ruba Ibrahim, Abraham Nyska, Susan A Elmore, Molly Boyle, Yuval Ramot","doi":"10.1177/01926233251322767","DOIUrl":"https://doi.org/10.1177/01926233251322767","url":null,"abstract":"Toxicologic pathologists play a crucial role in the evaluation of animal studies for drugs, environmental chemicals, medical devices, and other agents to determine their safety and potential toxic effects. A significant challenge in this domain is the differentiation between incidental or procedural changes and genuine treatment-related effects. Correct identification and interpretation of such findings are essential to ensure that safety assessments are accurate and reliable for subsequent approval for human use. This review presents several cases in which non-test item-related findings were encountered. By examining procedure-related findings and considering spontaneous background pathology, we underscore the need for meticulous pathological evaluation and proper contextual understanding to avoid misinterpretations that could lead to erroneous conclusions about a substance's safety profile. The insights shared in this review aim to enhance the proficiency of toxicologic pathologists in recognizing and managing various interpretative challenges, with the goal of ultimately improving the accuracy of toxicological assessments, thereby contributing to the safe development of new therapeutics and medical devices and sound characterization of potentially hazardous substances in our environment.","PeriodicalId":23113,"journal":{"name":"Toxicologic Pathology","volume":" ","pages":"1926233251322767"},"PeriodicalIF":1.4,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143731190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Mini Review: Spatial Transcriptomics to Decode the Central Nervous System. 小型评论：空间转录组学解码中枢神经系统

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-03-22 DOI: 10.1177/01926233251325204

Benedek Pesti, Xavi Langa, Nadine Kumpesa, Alberto Valdeolivas, Marc Sultan, Sven Rottenberg, Kerstin Hahn

引用次数: 0

Proceedings of the 2023 Annual Scientific Meeting of the French Society of Toxicologic Pathology (SFPT) on Preclinical Development and Therapeutic Applications of mRNA-Based Technologies.

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-03-20 DOI: 10.1177/01926233251326089

Pierluigi Fant, Sébastien Laurent, Paul Desert, Behazine Combadière, Xavier Palazzi, Shambhunath Choudhary, Frédéric Gervais, Karine Broudic, Roberta Rossi, Béatrice E Gauthier

引用次数: 0

Scientific and Regulatory Policy Committee Points to Consider* for Determining and Reporting Cause of Death/Moribundity in Non-Rodent Species in Toxicity Studies.

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-03-20 DOI: 10.1177/01926233251321781

Karyn Colman, Kathleen A Funk, Michael Boyle, Sebastian Brennan, Gary Cain, Curtis Colleton, Laura Dill Morton, Anna Maria Giusti, Eric Jacquinet, Lisa LaFranco-Scheuch, Luann McKinney, Elizabeth Neyens, Annette Romeike, Shim-Mo Hayashi, John L Vahle, Lindsay Tomlinson

{"title":"Scientific and Regulatory Policy Committee Points to Consider* for Determining and Reporting Cause of Death/Moribundity in Non-Rodent Species in Toxicity Studies.","authors":"Karyn Colman, Kathleen A Funk, Michael Boyle, Sebastian Brennan, Gary Cain, Curtis Colleton, Laura Dill Morton, Anna Maria Giusti, Eric Jacquinet, Lisa LaFranco-Scheuch, Luann McKinney, Elizabeth Neyens, Annette Romeike, Shim-Mo Hayashi, John L Vahle, Lindsay Tomlinson","doi":"10.1177/01926233251321781","DOIUrl":"https://doi.org/10.1177/01926233251321781","url":null,"abstract":"The Cause of Death in Non-Rodents (CODN) Working Group is an initiative under the Scientific and Regulatory Policy Committee (SRPC) of the Society of Toxicologic Pathology (STP), focused on understanding existing practices and expectations among pharmaceutical companies, academic entities, and contract research organizations (CROs) when it comes to identifying and reporting the \"Cause of Death\" (COD) or moribundity for early or unplanned necropsies in non-rodent animal species (mainly non-human primates [NHP] and dogs) within both GLP (Good Laboratory Practice) and non-GLP toxicity studies. A survey was sent out to STP members to collect data on industry practices for determining COD in animals that underwent unscheduled euthanasia or were found deceased. Other non-rodent animals (such as pigs and rabbits) were also included to evaluate different approaches taken with various species. The insights obtained led to the development of \"Points to Consider\" for establishing and documenting the COD in large animal toxicity studies. Four key considerations include utilizing information from both control and treated animals in the study, consideration of COD for cohabiting or co-shipped non-study animals, including additional evaluations to help rule-in or rule-out specific causes, and recording the COD consistently in pathology databases or reports as a standard practice.","PeriodicalId":23113,"journal":{"name":"Toxicologic Pathology","volume":" ","pages":"1926233251321781"},"PeriodicalIF":1.4,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143664443","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

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

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-03-18 DOI: 10.1177/01926233251322124

引用次数: 0

Comparisons of the Sensitivity of Histopathological and Immunohistochemical Analyses With Blood Hormone Levels for Early Detection of Antithyroid Effects in Rats Treated With Promoters of Thyroid Hormone Metabolism.

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-03-13 DOI: 10.1177/01926233251316880

Hirotoshi Akane, Takeshi Toyoda, Kohei Matsushita, Mizuho Uneyama, Tomomi Morikawa, Tadashi Kosaka, Hitoshi Tajima, Hiroaki Aoyama, Kumiko Ogawa

{"title":"Comparisons of the Sensitivity of Histopathological and Immunohistochemical Analyses With Blood Hormone Levels for Early Detection of Antithyroid Effects in Rats Treated With Promoters of Thyroid Hormone Metabolism.","authors":"Hirotoshi Akane, Takeshi Toyoda, Kohei Matsushita, Mizuho Uneyama, Tomomi Morikawa, Tadashi Kosaka, Hitoshi Tajima, Hiroaki Aoyama, Kumiko Ogawa","doi":"10.1177/01926233251316880","DOIUrl":"https://doi.org/10.1177/01926233251316880","url":null,"abstract":"Although blood triiodothyronine (T3), thyroxine (T4), and thyroid-stimulating hormone (TSH) levels are useful for detecting antithyroid compounds in rodent toxicity studies, there are challenges with high variability due to sampling conditions. Here, we compared histopathological and immunohistochemical findings with blood hormone levels in rats treated with promoters of thyroid hormone metabolism to explore useful markers for hypothyroidism. Six-week-old male and female Sprague-Dawley rats (5/group) were administered phenobarbital sodium salt (NaPB) or nicardipine hydrochloride (NCD) by gavage for 28 days. Decreased serum T4 and increased TSH levels were detected at 100 mg/kg NaPB and 150 mg/kg NCD, whereas follicular cell hypertrophy occurred at lower doses of ≥ 30 mg/kg NaPB and ≥ 50 mg/kg NCD. There was no obvious change in T3 or T4 immunostaining in the thyroid unlike thyroid peroxidase (TPO) inhibitors, and uridine diphosphate-glucuronosyltransferase 1A6-positive area in the liver increased at doses lower than those affecting the serum T4 levels and generally the same as those at which hepatocellular hypertrophy and follicular cell hypertrophy were observed, indicating its usefulness in detecting thyroid hormone metabolism promoters. These results indicate that histopathology is useful for sensitive detection of hormone metabolism promoters and can be distinguished from TPO inhibitors by immunohistochemistry.","PeriodicalId":23113,"journal":{"name":"Toxicologic Pathology","volume":" ","pages":"1926233251316880"},"PeriodicalIF":1.4,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Recent Neuropathology Concepts.

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-03-13 DOI: 10.1177/01926233251320056

Pierre Maliver, Julie Boisclair, Ingrid Pardo, Luisa Bell, Kerstin Hahn, Benedek Pesti, Stefanie Arms, Elizabeth Galbreath

引用次数: 0