Between-Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical Trial.

Again using FP C max as an example metric, the estimated between‐batch variance (0.0598) was 1.7‐fold larger than the estimated residual variance (0.0353) and was a highly significant contributor to total variability ( P < 0.0001).

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