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Predictivity/Translatability of Toxicities Observed in Nonclinical Toxicology Studies to Clinical Safety Outcomes in Drug Development: Case Examples.
Stagg, Nicola J; Ghantous, Hanan N; Roth, Robert; Hastings, Kenneth L.
Afiliação
  • Stagg NJ; Safety Assessment, Genentech Inc, South San Francisco, CA, USA.
  • Ghantous HN; FDA, Silver Spring, MD, USA.
  • Roth R; Department of Pharmacology and Toxicology, Institute for Integrative Toxicology, Michigan State University, East Lansing, MI, USA.
  • Hastings KL; Hastings Toxicology Consulting LLC, Mount Airy, MD, USA.
Int J Toxicol ; 39(2): 141-150, 2020.
Article em En | MEDLINE | ID: mdl-31875744
Nonclinical toxicology studies are conducted to characterize the potential toxicities and establish a safe starting dose for new drugs in clinical studies, but the question remains as to how predictable/translatable the nonclinical safety findings are to humans. In many cases, there is good concordance between nonclinical species and patients. However, there are cases for which there is a lack of predictivity or translatability that led to early termination of clinical studies due to unanticipated toxicities or early termination of programs before making it to the clinic due to unacceptable nonclinical toxicities assumed to be translatable. A few case examples of safety findings that are translatable versus safety findings that are not translatable and why they are not translateable were presented as a symposium at the 38th Annual Meeting of the American College of Toxicology in Palm Springs, California, and are discussed in this article.
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Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Avaliação Pré-Clínica de Medicamentos Tipo de estudo: Prognostic_studies / Risk_factors_studies Limite: Animals / Humans Idioma: En Revista: Int J Toxicol Assunto da revista: TOXICOLOGIA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Avaliação Pré-Clínica de Medicamentos Tipo de estudo: Prognostic_studies / Risk_factors_studies Limite: Animals / Humans Idioma: En Revista: Int J Toxicol Assunto da revista: TOXICOLOGIA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Estados Unidos