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A SIMULATION-BASED DECISION GUIDE TO EVALUATE MISSING DATA IN BA/BE STUDIES

PRESENTED TO: ASCPT 2024 by BioPharma Services
PRESENTED BY: VT. NGUYEN, MN. L, J. HE & J. OLDENHOF

PURPOSE

Clinical studies are, albeit well-controlled, not immune to missing data. BA/BE studies are exceptionally vulnerable due to the small sample size. To include or not to include, that is the question.

Multiple scenarios of missing data around Cmax were simulated to assess the impact of including or excluding incomplete data on BA/BE results.

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