Pharmacokinetic and Statistical Analysis of BE Data - BEBAC ...

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Pharmacokinetic and Statistical Analysis of BE Data Example datasets (EMA) •Q&A document (March 2011) •Data set I RTRT | TRTR full replicate, 77 subjects, imbalanced, incomplete • FDA s WR 0.446 ≥0.294 → apply RSABE (CV WR 46.96%) a. critbound –0.0921 ≤0 and b. PE 115.46% ⊂ 80.00–125.00% • EMA ‣CV WR 46.96% → apply ABEL (> 30%) ‣ Scaled Acceptance Range: 71.23–140.40% ‣ Method A: 90% CI 107.11–124.89% ⊂ AR; PE 115.66% ‣ Method B: 90% CI 107.17–124.97% ⊂ AR; PE 115.73% 1 st MENA Regulatory Conference on Bioequivalence, Biowaivers, Bioanalysis and Dissolution | Amman, 23 – 24 September 2013 44 • 50
Pharmacokinetic and Statistical Analysis of BE Data Example datasets (EMA) •Q&A document (March 2011) •Data set II TRR | RTR | RRT partial replicate, 24 subjects, balanced, complete • FDA s WR 0.114
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