Contributors: GL initiated the ecological and cohort studies, formulated the study aims, designed the layouts, organised the data collection, and participated in the statistical analysis and interpretation of results and in writing the paper. KB participated in collecting and interpreting results for the cohort study. JR participated in the statistical analysis and interpretation of the data an...

Randomized evidence from clinical trials and naturalistic evidence collected from pharmacoepidemiology and pharmacovigilance activities both contribute to the initial and continuous assessment of the benefits and risks of a drug, ie, the balance between therapeutic efficacy and safety risks. Benefit-risk assessment (BRA) mainly relies on a qualitative assessment of quantitative data. Current at...

1Pharmerit International, Bethesda, MD, USA; 2Center for Pharmacoepidemiology and Pharmacoeconomic Research, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA; 3Division of Pulmonary, Critical Care, Sleep, and Allergy, Department of Medicine, University of Illinois at Chicago, Chicago, IL, USA; 4Center of Pharmaceutical Outcomes Research, Department of Pharmacy Practice, ...

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Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, 3508 TB, Utrecht, The Netherlands, Brocacef Ziekenhuisfarmacie, 3600 AB, Maarssen, The Netherlands, Department of Clinical Chemistry and Department of Hematology, University Medical Center Utrecht, 3508 GA, Utrecht, The Netherlands, and Clinical Pharmacy, University Med...

Pharmacoepidemiology has been defined as “the study of the distribution and determinants of drugrelated events in populations and the application of this study to efficacious drug treatment” [26]. Similar definitions have been given by several authors [37, 53]. The term “drug” in the definition is generally understood to include biologics, such as vaccines, and the populations are understood to...

Drug-related problems such as overuse of injectable drug products and antimicrobials, increased cost of drug therapy, polypharmacy, and adverse drug reactions (ADRs) are prevalent in the healthcare settings of Nepal. To date, no new drug development processes or clinical trials have been conducted in Nepal, despite the fact that studies of real life situations are an essential tool for monitori...