Board on Health Sciences Policy & Institute of Medicine 
Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products [PDF ebook] 
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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 from imperfect...

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Language English ● Format PDF ● Pages 150 ● ISBN 9780309310017 ● Editor Anne B. Claiborne & Denise Caruso ● Publisher National Academies Press ● Published 2014 ● Downloadable 3 times ● Currency EUR ● ID 7144594 ● Copy protection Adobe DRM
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