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

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

doi:10.1002/cpt.203

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

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

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

39 Citations (Scopus)

Abstract

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 language	English
Pages (from-to)	522-533
Number of pages	12
Journal	Clinical Pharmacology & Therapeutics
Volume	98
Issue number	5
DOIs	https://doi.org/10.1002/cpt.203
Publication status	Published - Nov-2015

Keywords

NONPRESCRIPTION DRUGS
DECISION-MAKING

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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. (2015). Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions. Clinical Pharmacology & Therapeutics, 98(5), 522-533. https://doi.org/10.1002/cpt.203

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abstract = "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.",

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

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Pignatti, F, Ashby, D, Brass, EP, Eichler, H-G, Frey, P, Hillege, HL, Hori, A, Levitan, B, Liberti, L, Loefstedt, RE, McAuslane, N, Micaleff, A, Noel, RA, Postmus, D, Renn, O, Sabourin, BJ, Salmonson, T & Walker, S 2015, 'Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions', Clinical Pharmacology & Therapeutics, vol. 98, no. 5, pp. 522-533. https://doi.org/10.1002/cpt.203

TY - JOUR

T1 - Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines

T2 - Current Status and Possible Future Directions

AU - Pignatti, F.

AU - Ashby, D.

AU - Brass, E. P.

AU - Eichler, H-G

AU - Frey, P.

AU - Hillege, H. L.

AU - Hori, A.

AU - Levitan, B.

AU - Liberti, L.

AU - Loefstedt, R. E.

AU - McAuslane, N.

AU - Micaleff, A.

AU - Noel, R. A.

AU - Postmus, D.

AU - Renn, O.

AU - Sabourin, B. J.

AU - Salmonson, T.

AU - Walker, S.

PY - 2015/11

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N2 - 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.

AB - 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.

KW - NONPRESCRIPTION DRUGS

KW - DECISION-MAKING

U2 - 10.1002/cpt.203

DO - 10.1002/cpt.203

M3 - Review article

SN - 0009-9236

VL - 98

SP - 522

EP - 533

JO - Clinical Pharmacology & Therapeutics

JF - Clinical Pharmacology & Therapeutics

IS - 5

ER -

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

Abstract

Keywords

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