Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions-Reference-Cited by-同舟云学术

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

Published:2015-09-11 Issue:5 Volume:98 Page:522-533
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Pignatti F¹,Ashby D²,Brass EP³,Eichler H-G¹,Frey P⁴,Hillege HL⁵,Hori A⁶,Levitan B⁷,Liberti L⁸,Löfstedt RE⁹,McAuslane N⁸,Micaleff A¹⁰,Noel RA¹¹,Postmus D¹,Renn O¹²,Sabourin BJ¹³,Salmonson T¹⁴,Walker S⁸

Affiliation:

1. The European Medicines Agency; London United Kingdom

2. School of Public Health; Imperial College London; London United Kingdom

3. Department of Medicine; Harbor-UCLA Medical Center; Torrance California USA

4. Food and Drug Administration; Silver Spring Maryland USA

5. University of Groningen; Groningen The Netherlands

6. Pharmaceuticals and Medical Devices Agency; Tokyo Japan

7. Janssen Pharmaceutical Research and Development; Titusville New Jersey USA

8. Centre for Innovation in Regulatory Science (CIRS); London United Kingdom

9. Risk Research Group, Centre for Environmental Strategy; University of Surrey; Guildford United Kingdom

10. Merck Serono; Geneva Switzerland

11. Eli Lilly and Company; Indianapolis Indiana USA

12. Institut für Sozialwissenschaften; Universität Stuttgart; Stuttgart Germany

13. Health Canada; Ottawa Ontario Canada

14. Läkemedelsverket; Uppsala Sweden

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference44 articles.

1. European Medicines Agency Benefit-risk methodology project: work package 1 report: description of the current practice of benefit-risk assessment for centralised procedure products in the EU Regulatory Network http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000314.jsp&mid=WC0b01ac0580223ed6 2011

2. US Food and Drug Administration Structured approach to benefit-risk assessment in drug regulatory decision-making http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf 2013

3. Assessing the benefit-risk for new drugs: are the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and the Division of Metabolism and Endocrinology Products in sync?;Brass;Diabetes Care,2013

4. Weighing benefits and risks--the FDA's review of prasugrel;Unger;N. Engl. J. Med.,2009

5. Anticoagulant options--why the FDA approved a higher but not a lower dose of dabigatran;Beasley;N. Engl. J. Med.,2011

Cited by 38 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. The Brighton collaboration standardized module for vaccine benefit-risk assessment;Vaccine;2023-12

2. Methodological guidelines and publications of benefit–risk assessment for health technology assessment: a scoping review protocol;BMJ Open;2023-12

3. Regulatory benefit–risk assessment of oncology drugs: A systematic review of FDA and EMA approvals;Drug Discovery Today;2023-10

4. Appropriate design and reporting of superiority, equivalence and non-inferiority clinical trials incorporating a benefit–risk assessment: the BRAINS study including expert workshop;Health Technology Assessment;2023-10

5. Benefit-risk assessment of vaccines;Vaccine;2023-08