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Characterizing "Adversity" of Pathology Findings in Nonclinical Toxicity Studies: Results from the 4th ESTP International Expert Workshop.
Palazzi, Xavier; Burkhardt, John E; Caplain, Henri; Dellarco, Vicki; Fant, Pierluigi; Foster, John R; Francke, Sabine; Germann, Paul; Gröters, Sibylle; Harada, Takanori; Harleman, Johannes; Inui, Kosei; Kaufmann, Wolfgang; Lenz, Barbara; Nagai, Hirofumi; Pohlmeyer-Esch, Gabriele; Schulte, Agnes; Skydsgaard, Mikala; Tomlinson, Lindsay; Wood, Charles E; Yoshida, Midori.
Afiliación
  • Palazzi X; Sanofi, Vitry-sur-Seine, France xavier.palazzi@sanofi.com.
  • Burkhardt JE; Pfizer Inc., Groton, CT, USA.
  • Caplain H; Sanofi, Vitry-sur-Seine, France.
  • Dellarco V; Independent Consultant, Silver Spring, Maryland, USA.
  • Fant P; WIL Research, a Charles River Company, Lyon, France.
  • Foster JR; Tox Path Science, Congleton, Cheshire, UK.
  • Francke S; U.S. FDA, College Park, Maryland, USA.
  • Germann P; AbbVie, Ludwigshafen, Germany.
  • Gröters S; BASF, Ludwigshafen, Germany.
  • Harada T; Institute of Environmental Toxicology, Ibaraki, Japan.
  • Harleman J; Fresenius Kabi, Bad Homburg, Germany.
  • Inui K; Ishihara Sangyo Kaisha, Ltd., Osaka, Japan.
  • Kaufmann W; Merck, Darmstadt, Germany.
  • Lenz B; Roche Pharmaceutical Research and Early Development, Basel, Switzerland.
  • Nagai H; Takeda Pharmaceutical Company Limited, Fujisawa, Kanagawa, Japan.
  • Pohlmeyer-Esch G; Kaleidis Consultancy, Saint-Louis, France.
  • Schulte A; Federal Institute for Risk Assessment, Berlin, Germany.
  • Skydsgaard M; Novo Nordisk A/S, Måløv, Denmark.
  • Tomlinson L; Pfizer Inc., Groton, CT, USA.
  • Wood CE; Office of Research and Development, U.S. EPA, Research Triangle Park, North Carolina, USA.
  • Yoshida M; Food Safety Commission, Cabinet Office, Tokyo, Japan.
Toxicol Pathol ; 44(6): 810-24, 2016 08.
Article en En | MEDLINE | ID: mdl-27102650
ABSTRACT
The identification of adverse health effects has a central role in the development and risk/safety assessment of chemical entities and pharmaceuticals. There is currently a need for better alignment regarding how nonclinical adversity is determined and characterized. The European Society of Toxicologic Pathology (ESTP) therefore coordinated a workshop to review available definitions of adversity, weigh determining and qualifying factors of adversity based on case examples, and recommend a practical approach to define and characterize adversity in toxicology reports, to serve as a valuable prerequisite for future organ- or lesion-specific workshops planned by the ESTP.
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Toxicología / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos Tipo de estudio: Diagnostic_studies / Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Animals / Humans Idioma: En Revista: Toxicol Pathol Año: 2016 Tipo del documento: Article País de afiliación: Francia
Texto completo
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Toxicología / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos Tipo de estudio: Diagnostic_studies / Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Animals / Humans Idioma: En Revista: Toxicol Pathol Año: 2016 Tipo del documento: Article País de afiliación: Francia