Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future DirectionsPignatti, F., Ashby, D., Brass, E. P., Eichler, H-G., Frey, P., Hillege, H. L., Hori, A., Levitan, B., Liberti, L., Loefstedt, R. E., McAuslane, N., Micaleff, A., Noel, R. A., Postmus, D., Renn, O., Sabourin, B. J., Salmonson, T. & Walker, S., Nov-2015, In : Clinical Pharmacology & Therapeutics. 98, 5, p. 522-533 12 p.
Research output: Contribution to journal › Review article › Academic › peer-review
Structured frameworks for benefit-risk analysis in drug licensing decisions are being implemented across a number of regulatory agencies worldwide. The aim of these frameworks is to aid the analysis and communication of the benefit-risk assessment throughout the development, evaluation, and supervision of medicines. In this review, authors from regulatory agencies, pharmaceutical companies, and academia share their views on the different frameworks and discuss future directions.
|Number of pages||12|
|Journal||Clinical Pharmacology & Therapeutics|
|Publication status||Published - Nov-2015|
- NONPRESCRIPTION DRUGS, DECISION-MAKING