Bioequivalence and Bioavailability Forum

Dear All,

I had a doubt, when I was reading an SOP of one of our client. The following are the points which are new to me that I follow while doing the analysis:

Do not consider half-life, Kel, and AUC0-inf for analysis, if (1) the resulting half-life value is longer than the time interval over which Kel is determined, (2) the last three terminal points are used to determine Kel and either the middle or the last point is higher than the preceding point, or (3) the resulting adjusted R2 value is less than 0.8.

If the resulting half-life value is longer than the time interval over which Kel is determined, then explore an interval that is longer than the estimated half-life. Choose the interval with the next highest adjusted R2 value and assess the decrease in the adjusted R2 value to determine if a reliable estimation of the Kel is possible.

If the last 2 or more consecutive scheduled time points are missing in the elimination phase and the reportable concentration of the last collected sample is non-zero, then exclude that subject’s period data from AUC0-t analysis. For the subjects with missing samples, calculate a partial AUC0-t from the time of dosing to the time of last common sample collection if more than 10% of the AUC data are excluded from statistical analysis.

Does this process will accept by the USFDA? Why I am asking is this we had submitted all the studies to USFDA without doing this and even we got the approvals. So i am bit confused with this procedure?

Can anyone please enlighten me on this as I am a learner in Pharmacokinetics?

Thanks in Advance.