A Bayesian approach for individual‐level drug benefit‐risk assessment-Reference-Cited by-同舟云学术

A Bayesian approach for individual‐level drug benefit‐risk assessment

Published:2019-04-15 Issue:16 Volume:38 Page:3040-3052
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statistics in Medicine

Author:

Li Kan¹^ORCID,Luo Sheng²^ORCID,Yuan Sammy¹,Mt‐Isa Shahrul³⁴

Affiliation:

1. Merck Research LabMerck & Co North Wales Pennsylvania

2. Department of Biostatistics and BioinformaticsDuke University Medical Center Durham North Carolina

3. Biostatistics and Research Decision SciencesMSD London UK

4. School of Public HealthImperial College London London UK

Funder

National Institute of Neurological Disorders and Stroke

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/sim.8166

Reference40 articles.

1. Balancing benefit and risk of medicines: a systematic review and classification of available methodologies

2. Structured Benefit-Risk Assessment Across the Product Lifecycle: Practical Considerations

3. Food and Drug Administration.Structured approach to benefit‐risk assessment in drug regulatory decision‐making.https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm329758.pdf. Published2013. Accessed April 30 2018.

4. Food and Drug Administration.Benefit‐risk assessment in drug regulatory decision‐making.https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM602885.pdf. Published2013. Accessed October 30 2018.

5. European Medicines Agency.Benefit‐risk methodology project. Work package 4: Benefit‐risk tools and processes.http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/03/WC500123819.pdf. Published2012. Accessed April 30 2018.

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