Toxicologic Pathology最新文献_第2页

Case Report: Glioneuronal Hamartoma in the Cerebral Cortex of a Juvenile Cynomolgus Monkey (Macaca fascicularis).

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-03-13 DOI: 10.1177/01926233251320080

Elaine Debien, Felix Goulet, Lee Silverman, Esther Millette, Qian Wu

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2023 International Academy of Toxicologic Pathology (IATP) Satellite Symposium: "Medical Device Safety Assessment: Pathology and Toxicology Perspective". 2023 年国际毒理病理学学会 (IATP) 卫星研讨会："医疗设备安全评估：病理学和毒理学视角"。

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-02-12 DOI: 10.1177/01926233251316283

Flora Wegener, Antoine Alves, Uta Bussmeyer, Nicole V Soucy

{"title":"2023 International Academy of Toxicologic Pathology (IATP) Satellite Symposium: \"Medical Device Safety Assessment: Pathology and Toxicology Perspective\".","authors":"Flora Wegener, Antoine Alves, Uta Bussmeyer, Nicole V Soucy","doi":"10.1177/01926233251316283","DOIUrl":"https://doi.org/10.1177/01926233251316283","url":null,"abstract":"Medical devices represent a complex category of medicinal products with varying definitions depending on the regional jurisdiction of regulatory agencies. A common aspect of these definitions is that a medical device is intended to be used for specific medicinal purpose where the primary intended action of the device is not achieved through pharmacologic (or other chemical) means. While regional regulatory frameworks for medical devices are different than for pharmaceutical or biological products, medical device manufacturers are required to evaluate the safety and performance of these products in the context of their intended use. In biological safety evaluation, histopathology plays a relevant role in assessing medical device biocompatibility. This manuscript provides a broad overview of biocompatibility assessment with a deeper look at the role of the toxicologic pathologist in assessing innovative and emerging bone therapies. The content of this manuscript is based on individual presentations delivered at the 2023 International Academy of Toxicologic Pathology (IATP) Satellite Symposium held in conjunction with the Annual Congress of the European Society of Toxicologic Pathology (ESTP) on 26 September, in Basel, Switzerland.","PeriodicalId":23113,"journal":{"name":"Toxicologic Pathology","volume":" ","pages":"1926233251316283"},"PeriodicalIF":1.4,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143400062","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

Toxicologic Pathology Forum: Opinion on Digital Primary Read and Peer Review-Diving Head-First Into the Deep Digital Pool! 毒理病理学论坛：关于数字化初读和同行评审的意见--一头扎进数字化深潭！

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-02-01 Epub Date: 2024-12-12 DOI: 10.1177/01926233241303909

Krista M D La Perle

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Toxicologic Pathology Forum: Opinion on Digital Primary Read and Peer Review-Are We There Yet? 毒理学病理学论坛：对数字化初级阅读和同行评议的看法——我们到了吗？

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-02-01 Epub Date: 2025-01-18 DOI: 10.1177/01926233241303911

Kenneth A Schafer, Deepa B Rao

引用次数: 0

Historical Control Data of Spontaneous Lesions of Laboratory New Zealand White and Dutch Belted Rabbits (Oryctolagus Cuniculus) Used in Toxicity Studies.

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-02-01 Epub Date: 2025-01-26 DOI: 10.1177/01926233241298567

Davide Corbetta, Kaori Isobe, Romaisa Masood, Petrina Rogerson, Alys Bradley

{"title":"Historical Control Data of Spontaneous Lesions of Laboratory New Zealand White and Dutch Belted Rabbits (Oryctolagus Cuniculus) Used in Toxicity Studies.","authors":"Davide Corbetta, Kaori Isobe, Romaisa Masood, Petrina Rogerson, Alys Bradley","doi":"10.1177/01926233241298567","DOIUrl":"10.1177/01926233241298567","url":null,"abstract":"A retrospective study was performed to determine the incidences of spontaneous findings in control laboratory New Zealand White (NZW) and Dutch Belted (DB) rabbits. Terminal body and organ weights data were also collected. A total of 2170 NZW (526 males/1644 females), 100 DB rabbits (50 animals per sex), aged 4- to 7-month-old were obtained from 158 non-clinical studies evaluated between 2013 and 2022. The NZW rabbits had greater mean terminal body weights than DB strain. Mixed cell infiltration in the lung was the most recorded finding in both strains, followed by pulmonary inflammation/mononuclear cell infiltration. Differentiation between pulmonary \"infiltration\"/\"inflammation\" remained challenging as interpretation of guidelines for diagnostic terminology may vary amongst pathologists. Other common findings included mineralization and basophilia of the renal tubules; hepatic/renal mononuclear cell infiltration, all more common in females. Cysts were commonly recorded, with high prevalence in the oviduct, thyroid gland, ovary in NZW strain, while uterine, pituitary gland, and thyroid gland cysts were the most identified in DB rabbits. Neoplasms and infectious etiologies were absent. Most of the animals were sexually mature. To our knowledge, this is the most recent comprehensive study of spontaneous lesions and organ weights in both rabbit strains and should facilitate the differentiation of spontaneous and induced lesions in safety studies.","PeriodicalId":23113,"journal":{"name":"Toxicologic Pathology","volume":" ","pages":"187-209"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047917","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

Opinion on the Importance of Sharing Toxicologic Pathology Data for Educational and/or Scientific Purposes. 关于为教育和/或科学目的共享毒理病理学数据的重要性的意见。

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-02-01 Epub Date: 2024-11-18 DOI: 10.1177/01926233241296122

Eveline de Rijk, Phaedra Cole, Anna-Lena Frisk, Frederic Gervais, Joost Lensen, Barbara Lenz, Lars Mecklenburg, Flavia Pasello Dos Santos, Annette Romeike, Catherine Ross

{"title":"Opinion on the Importance of Sharing Toxicologic Pathology Data for Educational and/or Scientific Purposes.","authors":"Eveline de Rijk, Phaedra Cole, Anna-Lena Frisk, Frederic Gervais, Joost Lensen, Barbara Lenz, Lars Mecklenburg, Flavia Pasello Dos Santos, Annette Romeike, Catherine Ross","doi":"10.1177/01926233241296122","DOIUrl":"10.1177/01926233241296122","url":null,"abstract":"Sharing pathology data is critical for educational and scientific purposes. Since most pharmaceutical or (agro)chemical companies outsource nonclinical safety assessment studies to contract research organizations (CROs), the pathology data of those studies are not owned by the investigator but is the legal property of the respective company sponsoring the work. Although some companies have installed policies that govern sharing of pathology data, many companies generally do not allow the external use of data by either the CRO-based study pathologist or the sponsor pathologist. Policies for governing the external use of data vary significantly. In this article, we present an overview of the different approaches taken across different companies (CROs, pharmaceutical/chemical companies, or other institutes) for sharing pathology material for educational and/or scientific purposes. The results of a survey and interviews with legal departments of different companies will be presented (anonymously) and discussed. In addition, the importance of sharing pathology data is addressed, as well as the challenges and opportunities this presents. Suggestions will be provided regarding what material should be made available and what will be needed to achieve agreement for this to happen.","PeriodicalId":23113,"journal":{"name":"Toxicologic Pathology","volume":" ","pages":"218-229"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142669315","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

Virtual Control Groups in Non-clinical Toxicity Studies: Impacts on Toxicologic Clinical Pathology Data Interpretation. 非临床毒性研究中的虚拟对照组：对毒理学临床病理数据解释的影响。

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-02-01 Epub Date: 2024-11-30 DOI: 10.1177/01926233241300310

Adeyemi O Adedeji, Adi Wasserkrug Naor

{"title":"Virtual Control Groups in Non-clinical Toxicity Studies: Impacts on Toxicologic Clinical Pathology Data Interpretation.","authors":"Adeyemi O Adedeji, Adi Wasserkrug Naor","doi":"10.1177/01926233241300310","DOIUrl":"10.1177/01926233241300310","url":null,"abstract":"One of the emerging concepts on the reduction of animal use in non-clinical studies is the use of virtual control group (VCG) to replace concurrent control group (CCG). The VCG involves the generation of a control data from historical control data to match a specific study design. This review focuses on two recently published proof-of-concept (POC) studies conducted in rats. One major issue that was consistently seen across these POC studies was the non-reproducibility of some quantitative endpoints between the CCG and the VCG, with clinical pathology parameters being the most affected. The inconsistencies observed with the clinical pathology parameters when using VCGs may lead to: (1) misconception about the accuracy and sensitivity of traditional clinical pathology biomarkers and its implications on safety monitoring in the clinic; (2) inability to correctly identify and characterize organ dysfunctions; (3) interference with the weight-of-evidence approach used in identifying hazards in toxicologic clinical pathology and toxicology studies at large; and (4) wrong interpretations and data reproducibility issues. Other alternatives to reduce animal use in toxicology studies are also discussed including blood microsampling for toxicokinetics, scientifically justified use of recovery animals, and appropriate use and continuous investments in new alternative methods.","PeriodicalId":23113,"journal":{"name":"Toxicologic Pathology","volume":" ","pages":"164-172"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11909775/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142755453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

IHI VICT3R: Developing and Implementing Virtual Control Groups to Reduce Animal Use in Toxicology Research. 开发和实施虚拟控制组以减少毒理学研究中动物的使用。

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-02-01 Epub Date: 2024-12-12 DOI: 10.1177/01926233241303906

Thomas Steger-Hartmann, Ferran Sanz, Frank Bringezu, Inari Soininen

{"title":"IHI VICT3R: Developing and Implementing Virtual Control Groups to Reduce Animal Use in Toxicology Research.","authors":"Thomas Steger-Hartmann, Ferran Sanz, Frank Bringezu, Inari Soininen","doi":"10.1177/01926233241303906","DOIUrl":"10.1177/01926233241303906","url":null,"abstract":"The virtual control group (VCG) concept was originally developed in the IMI2 project eTRANSAFE, using data of control animals which pharmaceutical companies have accrued over decades from animal toxicity studies. This control data could be repurposed to create virtual control animals to reduce or replace concurrent controls in animal studies. Initial work demonstrated the general feasibility of the VCG concept, but implementation requires significant further collaborative efforts. The new Innovative Health Initiative (IHI) project VICT3R aims to address these challenges and to obtain regulatory acceptance for the VCG concept. To achieve these goals, VICT3R will build a database comprising high-quality, standardized, and duly annotated control animal data from past and forthcoming toxicity studies. The VICT3R project will create workflows and computational tools to generate adequate VCGs based on statistical and artificial intelligence (AI) approaches. The validity, reproducibility, and robustness of the resulting VCGs will be assessed by comparing the performance of their use with that of real control groups.","PeriodicalId":23113,"journal":{"name":"Toxicologic Pathology","volume":" ","pages":"230-233"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814225","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

Historical Control Background Incidence of Spontaneous Nonneoplastic Lesions of Sprague Dawley Rats in 104-Week Carcinogenicity Studies. 在为期 104 周的致癌性研究中，Sprague Dawley 大鼠自发性非肿瘤性病变的历史控制背景发生率。

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-02-01 Epub Date: 2024-10-29 DOI: 10.1177/01926233241289116

Marie Bockenstedt, Amit Kumar, Victoria Laast, Alok Sharma

{"title":"Historical Control Background Incidence of Spontaneous Nonneoplastic Lesions of Sprague Dawley Rats in 104-Week Carcinogenicity Studies.","authors":"Marie Bockenstedt, Amit Kumar, Victoria Laast, Alok Sharma","doi":"10.1177/01926233241289116","DOIUrl":"10.1177/01926233241289116","url":null,"abstract":"Microscopic observation data collected from approximately 1800 male and female Sprague Dawley (SD) control rats used on 104-week carcinogenicity studies performed at North American Labcorp Early Development, Inc, Madison, WI, were retrospectively evaluated for spontaneous nonneoplastic findings. This study provides incidence of the most common spontaneous nonneoplastic microscopic findings in each organ system of SD rats encountered during 104-week carcinogenicity studies. Some of the most common spontaneous background findings were cardiomyopathy; chronic progressive nephropathy; uterine cystic endometrial hyperplasia; prostate inflammation; pulmonary alveolar macrophage infiltrates; hepatocyte vacuolation, bile duct hyperplasia, and basophilic foci in the liver; pancreatic fibrosis; splenic extramedullary hematopoiesis and pigment; decreased lymphocytes and epithelial hyperplasia in the thymus; ventral brain compression; cystic degeneration and hyperplasia of the adrenal cortex; and mammary gland hyperplasia. The most common nonneoplastic findings in male SD rats were chronic progressive nephropathy (80.9%) and rodent progressive cardiomyopathy (73.2%). The most common nonnenoplastic findings in female SD rats were cystic degeneration of the adrenal cortex (64.7%) and ventral compression of the brain due to pituitary neoplasms (62.7%).","PeriodicalId":23113,"journal":{"name":"Toxicologic Pathology","volume":" ","pages":"173-186"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142523192","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

Thank You to Reviewers.

IF 1.4 4区医学

Toxicologic Pathology Pub Date : 2025-01-30 DOI: 10.1177/01926233251315826

引用次数: 0