Literature DB >> 26261064

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

F Pignatti1, D Ashby2, E P Brass3, H-G Eichler1, P Frey4, H L Hillege5, A Hori6, B Levitan7, L Liberti8, R E Löfstedt9, N McAuslane8, A Micaleff10, R A Noel11, D Postmus1, O Renn12, B J Sabourin13, T Salmonson14, S Walker8.   

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.
© 2015 American Society for Clinical Pharmacology and Therapeutics.

Mesh：

Year:  2015        PMID： 26261064     DOI： 10.1002/cpt.203

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  11 in total

Review 1.  Pharmaceutical Benefit-Risk Communication Tools: A Review of the Literature.

Authors:  Dominic Way; Hortense Blazsin; Ragnar Löfstedt; Frederic Bouder
Journal:  Drug Saf       Date:  2017-01       Impact factor: 5.606

Review 2.  The value of anticancer drugs - a regulatory view.

Authors:  Francesco Pignatti; Ulla Wilking; Douwe Postmus; Nils Wilking; Julio Delgado; Jonas Bergh
Journal:  Nat Rev Clin Oncol       Date:  2021-12-06       Impact factor: 66.675

3.  Adverse Drug Event Discovery Using Biomedical Literature: A Big Data Neural Network Adventure.

Authors:  Ahmad P Tafti; Jonathan Badger; Eric LaRose; Ehsan Shirzadi; Andrea Mahnke; John Mayer; Zhan Ye; David Page; Peggy Peissig
Journal:  JMIR Med Inform       Date:  2017-12-08

4.  Advancing regulatory science, advancing regulatory practice.

Authors:  Xavier Kurz
Journal:  Pharmacoepidemiol Drug Saf       Date:  2017-02-21       Impact factor: 2.890

Review 5.  Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.

Authors:  Magdalena Bujar; Neil McAuslane; Stuart R Walker; Sam Salek
Journal:  Front Pharmacol       Date:  2017-04-10       Impact factor: 5.810

6.  Can Standardisation of the Public Assessment Report Improve Benefit-Risk Communication?

Authors:  Andrea Keyter; Sam Salek; Shabir Banoo; Stuart Walker
Journal:  Front Pharmacol       Date:  2020-06-17       Impact factor: 5.810

7.  A WHO tool for risk-based decision making on blood safety interventions.

Authors:  Mart P Janssen; C Micha Nuebling; François-Xavier Lery; Yuyun S Maryuningsih; Jay S Epstein
Journal:  Transfusion       Date:  2020-12-25       Impact factor: 3.157

8.  Associations between uncertainties identified by the European Medicines Agency and national decision making on reimbursement by HTA agencies.

Authors:  Lourens T Bloem; Rick A Vreman; Niels W L Peeters; Jarno Hoekman; Menno E van der Elst; Hubert G M Leufkens; Olaf H Klungel; Wim G Goettsch; Aukje K Mantel-Teeuwisse
Journal:  Clin Transl Sci       Date:  2021-05-01       Impact factor: 4.689

9.  Early Health Technology Assessment during Nonalcoholic Steatohepatitis Drug Development: A Two-Round, Cross-Country, Multicriteria Decision Analysis.

Authors:  Aris Angelis; Mark Thursz; Vlad Ratziu; Alastair O'Brien; Lawrence Serfaty; Ali Canbay; Ingolf Schiefke; Joao Bana E Costa; Pascal Lecomte; Panos Kanavos
Journal:  Med Decis Making       Date:  2020-08       Impact factor: 2.583

10.  Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression.

Authors:  Eva G Katz; David Hough; Teodora Doherty; Rosanne Lane; Jaskaran Singh; Bennett Levitan
Journal:  Clin Pharmacol Ther       Date:  2020-10-13       Impact factor: 6.875
View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.