Number needed to harm in the post-marketing safety evaluation: results for rosiglitazone and pioglitazone

Drug-safety alerts issued by regulatory authorities: usefulness of meta-analysis in predicting risks earlier

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Benefit-risk assessment in a post-market setting: a case study integrating real-life experience into benefit-risk methodology

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

(2014) Shahrul Mt-Isa et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making

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A Universal Framework for the Benefit-Risk Assessment of Medicines

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The Future of Population-Based Postmarket Drug Risk Assessment: A Regulator’s Perspective

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When does a difference make a difference? Interpretation of number needed to treat, number needed to harm, and likelihood to be helped or harmed

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The risks of risk aversion in drug regulation

(2013) Hans-Georg Eichler et al.   NATURE REVIEWS DRUG DISCOVERY

Cardiovascular Effects of Intensive Lifestyle Intervention in Type 2 Diabetes

(2013)   NEW ENGLAND JOURNAL OF MEDICINE

Evaluation of FDA safety-related drug label changes in 2010

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Rosiglitazone, Myocardial Ischemic Risk, and Recent Regulatory Actions

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A meta-analysis of serious adverse events reported with exenatide and liraglutide: Acute pancreatitis and cancer

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Market withdrawal of new molecular entities approved in the United States from 1980 to 2009

(2011) Zaina P. Qureshi et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Benefit-risk assessment: to quantify or not to quantify, that is the question

(2011) Zhong Yuan et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Rosiglitazone Revisited

(2010) Steven E. Nissen et al.   ARCHIVES OF INTERNAL MEDICINE

A Review of Quantitative Risk–Benefit Methodologies for Assessing Drug Safety and Efficacy—Report of the ISPOR Risk–Benefit Management Working Group

(2010) Jeff J. Guo et al.   VALUE IN HEALTH

Relative vs. absolute measures of benefit and risk: what’s the difference?

(2009) L. Citrome   ACTA PSYCHIATRICA SCANDINAVICA

Communicating benefit and risk

(2009) Trevor Baglin   BRITISH JOURNAL OF HAEMATOLOGY

Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial

(2009) Philip D Home et al.   LANCET

The Rosigliazone Meta-Analysis: Lessons for the future

(2008) J. J. Shuster et al.   DIABETES CARE

Benefits and Risks of Drug Treatments

(2008) Jan P. Vandenbroucke et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Evaluating drug toxicity signals: is a hierarchical classification of evidence useful or a hindrance?

(2008) T. P. van Staa et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY