Bioequivalence and Bioavailability Forum

Hi Cedric,

❝ ... 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.

In order to be able to exclude those subject who has predose > 5% Cmax firstly you need to have method to detect that concentration (hence the LLOQ of 5% of Cmax). To give an example, if the LLOQ of your method is 10% of the Cmax, what if a subject with predose of 8% of the Cmax? He/she should be excluded but you are unable to detect such subject because the predose concentration is below your LLOQ.