The role of quantitative safety evaluation in regulatory decision making of drugs

Association Between Analytic Strategy and Estimates of Treatment Outcomes in Meta-analyses

(2014) Agnes Dechartres et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Cardiovascular and mortality risks in older Medicare patients treated with varenicline or bupropion for smoking cessation: an observational cohort study

(2014) David J. Graham et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Risk of bias in industry-funded oseltamivir trials: comparison of core reports versus full clinical study reports

(2014) T. Jefferson et al.   BMJ Open

Cardiovascular and mortality risks in Parkinson's disease patients treated with entacapone

(2013) David J. Graham et al.   MOVEMENT DISORDERS

Dabigatran and Postmarketing Reports of Bleeding

(2013) Mary Ross Southworth et al.   NEW ENGLAND JOURNAL OF MEDICINE

The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety

(2012) Melissa A. Robb et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Design considerations, architecture, and use of the Mini-Sentinel distributed data system

(2012) Lesley H. Curtis et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot

(2012) Andrea J. Cook et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

The Columbia–Suicide Severity Rating Scale: Initial Validity and Internal Consistency Findings From Three Multisite Studies With Adolescents and Adults

(2011) Kelly Posner et al.   AMERICAN JOURNAL OF PSYCHIATRY

Secondary use of randomized controlled trials to evaluate drug safety: a review of methodological considerations

(2011) Tarek A Hammad et al.   Clinical Trials

Meta‐Analysis of a Possible Signal of Increased Mortality Associated with Cefepime Use

(2010) Peter W. Kim et al.   CLINICAL INFECTIOUS DISEASES

The Safety of Tiotropium — The FDA's Conclusions

(2010) Theresa M. Michele et al.   NEW ENGLAND JOURNAL OF MEDICINE

Reporting cumulative proportion of subjects with an adverse event based on data from multiple studies

(2010) Christy Chuang-Stein et al.   PHARMACEUTICAL STATISTICS

Inhaled Anticholinergics and Risk of Major Adverse Cardiovascular Events in Patients With Chronic Obstructive Pulmonary Disease

(2008) Sonal Singh   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION