Bioequivalence and Bioavailability Forum

Dear Dr_Dan,

Agree with your point but please consider one thing that the subject which are not getting qualify during initial analysis are getting qualify with the revised range.

In this case, the concentration obtain during repeat analysis of period which was showing zero or BLQ during initial study analysis having very less concentration. For example see below:

subject no. 13 during initial analysis showing only one period gets quantify concentration and the Cmax is around 23 ng/ml. second period of test has shown zero or BLQ. Now with the revised range both test period gets qualify and the Cmax is around 22 ng/ml (which was previously 23 ng/ml) and second period of test got Cmax 0.75 ng/ml.

Now in the point estimation of 4WC this mean of the test will affect the data.

there is some other subject also who has shown same kind of data or some deviation around 10-12% during repeat study analysis.

Now please let me know under such situation affect at the Cmax ratio is logical or not?

Regards,

Compliance