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Characterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical products
Paperback
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- Book Synopsis
- "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 data. Efforts
- Product Details
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- ISBN
- 9780309310000
- Format
- Paperback
- Publisher
- National Academies Press, (19 December 2014)
- Weight
- 567 grams
- Language
- English
- Dimensions
- 229 x 152 x 28 mm
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