Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products: Workshop Summary
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 are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutica…
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Produktdetails
Weitere Autoren: Board on Health Sciences Policy / Forum on Drug Discovery Development and
- ISBN: 978-0-309-31000-0
- EAN: 9780309310000
- Produktnummer: 17086166
- Verlag: Natl Academy Pr
- Sprache: Englisch
- Erscheinungsjahr: 2015
- Seitenangabe: 150 S.
- Masse: H22.8 cm x B15.1 cm x D1.2 cm 256 g
- Gewicht: 256
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