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Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products: Workshop Summary

Institute of Medicine, Board on Health Sciences Policy, Development, and Translation Forum on Drug Discovery




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 | #5240264 in Books |  2015-01-19 | Original language:English | PDF # 1 |  8.90 x1.10 x5.90l,1.25 | File type: PDF | 150 pages

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Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy f...

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