Bioequivalence and Bioavailability Forum

❝ The cut-off for excluding subjects (“substantial” carry-over from earlier periods in cross-over studies due to a too short wash-out phase) in many guidelines on BE is 5% of C_max.

Thanks for the clear explanation. A quick clarification.. the rules for excluding subjects with substantial carry-over should be the pre-dose level is greater than 5 % Cmax. what is the relationship between the predose < 5 % Cmax and LLOQ < 5 % Cmax.

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]