谷本学校 毒性質問箱
Online ISSN : 2436-5114
〈特集2〉ファーマコビジランス-Nonclinical and Clinical Joint Discussion-
8.Barriers to developing databases to assess non-clinical and clinical data concordance: Experience of the HESI Nonclinical and Clinical Safety Correlations Committee
Dr. James H. Kim
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解説誌・一般情報誌 フリー

2012 年 2012 巻 14 号 p. 82-83

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 Toxicology testing is predicated on the use of animal models for the prediction of adverse effects of chemicals in humans. The assumption that experimental animals are appropriate and relevant models of human toxicity responses is difficult to fully test for many chemicals. By contrast, pharmaceuticals typically have an extensive body of toxicology data from both animals and humans that could be used to test this assumption. These data are largely unpublished and confidential, residing in the databases and files of pharmaceutical companies.

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© 2012 Safety Evaluation Forum
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