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

by Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery Development and Translation, et al.

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...

• Format: Paperback
• Language: English
• ISBN: 0309310008
• ISBN13: 9780309310000
• Release Date: January 2015
• Publisher: National Academies Press
• Length: 150 Pages
• Weight: 1.25 lbs.
• Dimensions: 1.1" x 5.9" x 8.9"