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Scientific and Regulatory Policy Committee Brief Communication: 2019 Survey on Use of Digital Histopathology Systems in Nonclinical Toxicology Studies.
Forest, Thomas; Aeffner, Famke; Bangari, Dinesh S; Bawa, Bhupinder; Carter, Jonathan; Fikes, James; High, Wanda B; Hayashi, Shim-Mo; Jacobsen, Matthew; McKinney, LuAnn; Rudmann, Daniel; Steinbach, Thomas; Schumacher, Vanessa; Turner, Oliver C; Ward, Jerrold M; Willson, Cynthia J.
Afiliación
  • Forest T; Merck & Co., Inc., West Point, Pennsylvania, USA.
  • Aeffner F; Amgen, Inc., San Francisco, California, USA.
  • Bangari DS; Sanofi R&D, Framingham, Massachusetts, USA.
  • Bawa B; AbbVie, Inc., Chicago, Illinois, USA.
  • Carter J; Labcorp Early Development Laboratories Ltd, Harrogate, UK.
  • Fikes J; Biogen, Inc., Cambridge, Massachusetts, USA.
  • High WB; High Preclinical Pathology Consulting, Rochester, New York, USA.
  • Hayashi SM; Tokyo University of Agriculture and Technology, Fuchu, Japan.
  • Jacobsen M; National Institute of Health Sciences, Kawasaki, Japan.
  • McKinney L; AstraZeneca, Cambridge, UK.
  • Rudmann D; US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Steinbach T; Charles River Laboratories International, Inc., Wilmington, Massachusetts, USA.
  • Schumacher V; Experimental Pathology Laboratories, Inc., Research Triangle Park, North Carolina, USA.
  • Turner OC; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Ward JM; Novartis, East Hanover, New Jersey, USA.
  • Willson CJ; Global VetPathology, Montgomery Village, Maryland, USA.
Toxicol Pathol ; 50(3): 397-401, 2022 04.
Article en En | MEDLINE | ID: mdl-35321602
ABSTRACT
Histopathologic evaluation and peer review using digital whole-slide images (WSIs) is a relatively new medium for assessing nonclinical toxicology studies in Good Laboratory Practice (GLP) environments. To better understand the present and future use of digital pathology in nonclinical toxicology studies, the Society of Toxicologic Pathology (STP) formed a working group to survey STP members with the goal of creating recommendations for implementation. The survey was administered in December 2019, immediately before the COVID-19 pandemic, and the results suggested that the use of digital histopathology for routine GLP histopathology assessment was not widespread. Subsequently, in follow-up correspondence during the pandemic, many responding institutions either began investigating or adopting digital WSI systems to reduce employee exposure to COVID-19. Therefore, the working group presents the survey results as a pre-pandemic baseline data set. Recommendations for use of WSI systems in GLP environments will be the subject of a separate publication.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Toxicología / COVID-19 Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Toxicol Pathol Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Toxicología / COVID-19 Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Toxicol Pathol Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos