The Application, Challenges, and Advancement Toward Regulatory Acceptance of Digital Toxicologic Pathology: Results of the 7th ESTP International Expert Workshop (September 20-21, 2019).

Autor: Schumacher VL; 1529Roche Innovation Center Basel, Pharma Research and Early Development, F. Hoffmann-La Roche, Ltd, Basel, Switzerland., Aeffner F; Amgen Inc, Amgen Research, Translational Safety and Bioanalytical Sciences, South San Francisco, CA, USA., Barale-Thomas E; Janssen R&D, Beerse, Belgium., Botteron C; Sirius Pathology, Cruseilles, France., Carter J; 63899Covance Laboratories, Harrogate, United Kingdom., Elies L; 72810Bayer Crop Science Division, Sophia Antipolis, France.; 25913Charles River Laboratories, Lyon, France., Engelhardt JA; 448132Ionis Pharmaceuticals Inc, Carlsbad, CA, USA., Fant P; 25913Charles River Laboratories, Lyon, France., Forest T; Merck & Co, Inc, West Point, Pennsylvania, USA., Hall P; 35932UCB Pharma, Slough, United Kingdom., Hildebrand D; 1929GlaxoSmithKline, Ware, United Kingdom., Klopfleisch R; 9166Freie Universitaet Berlin, Institute of Veterinary Pathology, Berlin, Germany., Lucotte T; 56511Agence nationale de sécurité du médicament et des produits de santé (ANSM), Saint-Denis, France., Marxfeld H; 5184BASF SE, Ludwigshafen, Germany., Mckinney L; 4137US Food and Drug Administration, Silver Spring, MD, USA., Moulin P; Novartis, Basel, Switzerland., Neyens E; Elizabethtoxpath Consulting Inc, Vancouver, British Columbia, Canada., Palazzi X; Pfizer, Groton, CT, USA., Piton A; ALP Quality Systems, Sophia Antipolis, France., Riccardi E; 402057IDEXX Laboratories Ltd, Wetherby, United Kingdom., Roth DR; 69479Swissmedic, Bern, Switzerland., Rousselle S; StageBio, Thurmont, MD, USA., Vidal JD; Charles River, Mattawan, MI, USA., Williams B; 572272Department of Histopathology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.; Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom.
Jazyk: angličtina
Zdroj: Toxicologic pathology [Toxicol Pathol] 2021 Jun; Vol. 49 (4), pp. 720-737. Date of Electronic Publication: 2020 Dec 10.
DOI: 10.1177/0192623320975841
Abstrakt: With advancements in whole slide imaging technology and improved understanding of the features of pathologist workstations required for digital slide evaluation, many institutions are investigating broad digital pathology adoption. The benefits of digital pathology evaluation include remote access to study or diagnostic case materials and integration of analysis and reporting tools. Diagnosis based on whole slide images is established in human medical pathology, and the use of digital pathology in toxicologic pathology is increasing. However, there has not been broad adoption in toxicologic pathology, particularly in the context of regulatory studies, due to lack of precedence. To address this topic, as well as practical aspects, the European Society of Toxicologic Pathology coordinated an expert international workshop to assess current applications and challenges and outline a set of minimal requirements needed to gain future regulatory acceptance for the use of digital toxicologic pathology workflows in research and development, so that toxicologic pathologists can benefit from digital slide technology.
Databáze: MEDLINE
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