Structured Benefit-risk assessment: a review of key publications and initiatives on frameworks and methodologies-Reference-Cited by-同舟云学术

Structured Benefit-risk assessment: a review of key publications and initiatives on frameworks and methodologies

Published:2015-05-15 Issue:4 Volume:15 Page:324-332
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceut. Statist.

Author:

Mt-Isa Shahrul¹,Ouwens Mario²,Robert Veronique³,Gebel Martin⁴,Schacht Alexander⁵,Hirsch Ian⁶

Affiliation:

1. Imperial Clinical Trials Unit; School of Public Health, Imperial College London; London UK

2. Biometrics; Abbott Healthcare Products B.V; Weesp The Netherlands

3. Department of Biostatistics; Institut de Recherches Internationales Servier; Suresnes France

4. Global Integrated Analysis and Life Cycle Management Statistics; Bayer Healthcare; Wuppertal Germany

5. Global Statistical Sciences; Lilly Deutschland GmbH; Bad Homburg Germany

6. Biometrics and Information Sciences; AstraZeneca LP, Gaithersburg USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pst.1690/fullpdf

Reference66 articles.

1. U.S. Food and Drug Administration Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) 2013 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM346564.pdf?source=govdelivery

2. European Medicines Agency ICH guideline E2C (R2) on periodic benefit-risk evaluation report (PBRER) 2013

3. Food and drug administration prescription drug user fee act V benefit-risk plan; request for comments;Department of Health and Human Services Food and Drug Administration;Federal Register,2013

4. Department of Health and Human Services Food and Drug Administration Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making 2013 http://www.fda.gov/downloads/ForIndustry/ UserFees/PrescriptionDrugUserFee/UCM329758.pdf

5. Safe drugs and the cost of good intentions;Eichler;New England Journal of Medicine,2009

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