Batch-to-batch pharmacokinetic variability confounds current bioequivalence regulations: A dry powder inhaler randomized clinical trial.

While statistically significant between‐batch variability of the Test product was not found, the estimated between‐batch variance of Reference for FP C max , as an example metric, was 1.4‐fold larger than the estimated residual variance, and hence a highly significant contributor to total variability of the Reference product.

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