Publication

Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions

Pignatti, 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 journalReview articleAcademicpeer-review

  • F. Pignatti
  • D. Ashby
  • E. P. Brass
  • H-G Eichler
  • P. Frey
  • H. L. Hillege
  • A. Hori
  • B. Levitan
  • L. Liberti
  • R. E. Loefstedt
  • N. McAuslane
  • A. Micaleff
  • R. A. Noel
  • D. Postmus
  • O. Renn
  • B. J. Sabourin
  • T. Salmonson
  • S. Walker

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.

Original languageEnglish
Pages (from-to)522-533
Number of pages12
JournalClinical Pharmacology & Therapeutics
Volume98
Issue number5
Publication statusPublished - Nov-2015

    Keywords

  • NONPRESCRIPTION DRUGS, DECISION-MAKING

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