Regulatory Forum Opinion Piece*: Imaging Applications in Toxicologic Pathology—Recommendations for Use in Regulated Nonclinical Toxicity Studies
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DOI: 10.1177/0192623317710014
Abstract: Available imaging systems for use in preclinical toxicology studies increasingly show utility as important tools in the toxicologic pathologist’s armamentarium, permit longitudinal evaluation of functional and morphological changes in tissues, and provide important information such… read more here.
Keywords: toxicologic pathology; pathology; toxicology; regulatory forum ... See more keywords
Immunohistochemistry in Investigative and Toxicologic Pathology
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DOI: 10.1177/0192623318776907
Abstract: Immunohistochemistry (IHC) is a valuable tool in pathology. This review provides a brief description of the technical aspects of IHC and a detailed discussion on the variables that affect the results, interpretation, and reproducibility of… read more here.
Keywords: immunohistochemistry investigative; investigative toxicologic; toxicologic pathology; pathology ... See more keywords
Statistical Guidance for Reviewers of Toxicologic Pathology
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DOI: 10.1177/0192623318785097
Abstract: Study design, statistical analysis, interpretation of results, and conclusions should be a part of all research papers. Statistics are integral to each of these components and are therefore necessary to evaluate during manuscript peer review.… read more here.
Keywords: research; pathology statistical; toxicologic pathology; statistical guidance ... See more keywords
Toxicologic Pathology Forum*: Opinion on Integrating Innovative Digital Pathology Tools in the Regulatory Framework
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DOI: 10.1177/0192623319827485
Abstract: Digital pathology is defined as the ability to examine digitized microscopic slides and to generate qualitative and quantitative data. The field of digital pathology is rapidly evolving and has the potential to revolutionize toxicologic pathology.… read more here.
Keywords: innovative digital; toxicologic pathology; pathology; digital pathology ... See more keywords
Toxicologic Pathology Forum*: Opinion on Sexual Maturity and Fertility Assessment in Long-tailed Macaques (Macaca fascicularis) in Nonclinical Safety Studies
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DOI: 10.1177/0192623319831009
Abstract: If nonhuman primates represent the only relevant species for nonclinical safety evaluation of biotechnology-derived products, male and female fertility effects can be assessed in repeat dose toxicity studies given that sexually mature monkeys are used.… read more here.
Keywords: sexual maturity; toxicologic pathology; pathology; opinion ... See more keywords
Society of Toxicologic Pathology Digital Pathology and Image Analysis Special Interest Group Article*: Opinion on the Application of Artificial Intelligence and Machine Learning to Digital Toxicologic Pathology
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DOI: 10.1177/0192623319881401
Abstract: Toxicologic pathology is transitioning from analog to digital methods. This transition seems inevitable due to a host of ongoing social and medical technological forces. Of these, artificial intelligence (AI) and in particular machine learning (ML)… read more here.
Keywords: machine learning; article; toxicologic pathology; special interest ... See more keywords
IT/QA and Regulatory Aspects of Digital Pathology: Results of the 8th ESTP International Workshop
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DOI: 10.1177/01926233221113275
Abstract: Digital toxicologic histopathology has been broadly adopted in preclinical compound development for informal consultation and peer review. There is now increased interest in implementing the technology for good laboratory practice–regulated study evaluations. However, the implementation… read more here.
Keywords: aspects digital; toxicologic pathology; pathology; histopathology ... See more keywords
Toxicologic Pathology Forum: A Roadmap for Building State-of-the-Art Digital Image Data Resources for Toxicologic Pathology in the Pharmaceutical Industry
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DOI: 10.1177/01926233221132747
Abstract: Digitization of histologic slides brings with it the promise of enhanced toxicologic pathology practice through the increased application of computational methods. However, the development of these advanced methods requires access to substrate image data, that… read more here.
Keywords: pharmaceutical industry; toxicologic pathology; data resources; pathology ... See more keywords
Complex In Vitro Model Characterization for Context of Use in Toxicologic Pathology: Use Cases by Collaborative Teams of Biologists, Bioengineers, and Pathologists
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DOI: 10.1177/01926233241253811
Abstract: Complex in vitro models (CIVMs) offer the potential to increase the clinical relevance of preclinical efficacy and toxicity assessments and reduce the reliance on animals in drug development. The European Society of Toxicologic Pathology (ESTP)… read more here.
Keywords: use; toxicologic pathology; pathology; complex vitro ... See more keywords
A Minimal Approach to Demonstrate Concordance of Digital and Conventional Microscopy in Toxicologic Pathology
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DOI: 10.1177/01926233241255125
Abstract: Digitalization of pathology workflows has undergone a rapid evolution and has been widely established in the diagnostic field but remains a challenge in the nonclinical safety context due to lack of regulatory guidance and validation… read more here.
Keywords: pathology minimal; toxicologic pathology; pathology; nonclinical safety ... See more keywords
2023 International Academy of Toxicologic Pathology (IATP) Satellite Symposium: “Medical Device Safety Assessment: Pathology and Toxicology Perspective”
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DOI: 10.1177/01926233251316283
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… read more here.
Keywords: toxicologic pathology; pathology; medical device; toxicology ... See more keywords