Recommendations for benefit-risk assessment methodologies and visual representations-Reference-Cited by-同舟云学术

Recommendations for benefit-risk assessment methodologies and visual representations

Published:2016-01-22 Issue:3 Volume:25 Page:251-262
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Hughes Diana¹,Waddingham Ed²,Mt-Isa Shahrul²,Goginsky Alesia³,Chan Edmond⁴,Downey Gerald F.⁵,Hallgreen Christine E.²⁶,Hockley Kimberley S.²,Juhaeri Juhaeri⁷,Lieftucht Alfons⁸,Metcalf Marilyn A.⁹,Noel Rebecca A.¹⁰,Phillips Lawrence D.¹¹,Ashby Deborah²,Micaleff Alain¹²,

Affiliation:

1. Worldwide Safety Strategy; Pfizer; New York NY USA

2. Imperial Clinical Trials Unit; Imperial College London; London UK

3. Pfizer; New York NY USA

4. Oncology Signal Detection and Analytics Physician Team Lead, Division of Janssen-Cilag Ltd, Johnson & Johnson; Global Medical Organisation; High Wycombe Buckinghamshire UK

5. Amgen Limited; Cambridge UK

6. Faculty of Health and Medical Science, Department of Pharmacy, CORS; University of Copenhagen; Copenhagen Denmark

7. Pharmacoepidemiology; Global Pharmacovigilance and Epidemiology; Sanofi; Bridgewater NJ USA

8. Benefit-Risk Evaluation; RD Chief Medical Office; GlaxoSmithKline UK Ltd; Uxbridge UK

9. Benefit-Risk Evaluation; US Safety Mgmt; RD Chief Medical Office; GSK; NC USA

10. Benefit-Risk Assessment; Eli Lilly and Company, Lilly Corporate Center; Indianapolis IN USA

11. Department of Management; London School of Economics; London UK

12. MerckSerono SA; Geneva Switzerland

Funder

Innovative Medicines Initiative Joint Undertaking

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.3958/fullpdf

Reference49 articles.

1. CIOMS Working Group IV Benefit-risk balance for marketed drugs: evaluating safety signals http://www.cioms.ch/publications/g4-benefit-risk.pdf:

2. European Medicines Agency Benefit-risk methodology project http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000314.jsp&mid=WC0b01ac0580223ed6

3. Benefit-risk methodology project: update on work package 5: effects table pilot (phase I) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/02/WC500162036.pdf

4. Structured approach to benefit-risk assessment in drug regulatory decision-making http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm329758.pdf

5. Annex 1 - Grant Agreement N° 115004. PROTECT - Description of work; 2013 https://eroombayer.de/eRoom/PH-GDC-PI-SID/IMI-PROTECT/0_10a702

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