4/10/2023 0 Comments Fda periodic safety update reports![]() ![]() Patient compliance, inclusion/exclusion criteria, co-morbidity profiles, concomitant medicines and food intake, and monitoring are not the same in the real-world compared to the controlled environment of clinical trials exposing patients to more adverse drug reactions and adverse events. Unlike drug safety monitoring which is an ongoing aspect of preclinical research through the clinical trial phase and involves assessment of side effects during clinical trial, pharmacovigilance is focused on identifying adverse events in a ‘real-world’ setting. Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse events or any drug related problems.
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