A SIMULATION-BASED DECISION GUIDE TO EVALUATE MISSING DATA IN BIOEQUIVALENCE STUDIES
PRESENTED TO: AAPS 2023 by BioPharma Services
PRESENTED BY: J. K, MN. L, J. HE & J. OLDENHOF
PURPOSE
In bioequivalence (BE) studies with pharmacokinetic (PK) endpoints, selecting an adequate and robust sampling time is essential for reliable estimations of PK parameters and accurate BE assessment. Though the derived endpoints are approximations of drug characteristics and data points are inevitably missing in clinical trials, insufficient data undermine the precise determination of PK parameters. Although the impact of missing data on modeling approaches, analysis methods, and how to handle missing data in pharmacokinetic (PK) modeling has been
extensively studied, less known about the extent and consequences of incomplete PK data on BE assessment.
We conducted simulations with various extent of randomly incomplete sampling and investigated their effects on the BE results when impacted parameter(s) were included or excluded. The simulations cover multiple scenarios; however, this poster focuses on the measurement around the maximum concentration [Cmax (Tmax)] which is a critical parameter exhibiting significant variability in BE assessment.
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