alexa Use of Metabolites in Bioequivalence Decision Making

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Use of Metabolites in Bioequivalence Decision Making

To investigate whether the combined concentrations of the parent drug and its corresponding metabolite impacts the experimental design of bioequivalence studies. Enalpril and sildenafil were selected to assess bioequivalence as both drugs have active metabolites. The bioequivalence study of enalpril was conducted under fasting conditions, while the bioequivalence assessment of sildenafil was conducted under both fasting and fed conditions. role of metabolites in bioequivalence studies has been a contentious issue for many years. Many papers have published recommendations for the use of metabolite data based on anecdotal evidence from the results of bioequivalence studies. Such anecdotal evidence has validity, but the arguments lack weight because the "correct" answers are always unknown. A more promising area of exploration is recommendations based on simulated bioequivalence studies for which the "correct" answers are known, given the assumptions.

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