Bioequivalence and Bioavailability Forum

Dear Ratnakar!

❝ ❝ IMHO excluding a subject based on a too high residual AUC is neither based on statistics nor on PK, but only to fulfill EMA’s requirement. Personally I have no problem keeping the subject in the study, but truncate his/her AUC in the respective other treatment period as well.

❝

❝ Will there be any regulatory issue?

Sure there will be one. It’s against the guideline. If you want to follow GLs literally and think that you will never get a deficiency letter, good luck. On the other hand I have performed studies pretty straight against GLs, but only if I had strong reasons for doing so and laying down all planned procedures in the protocol. The more you deviate from any GL, the more intellectual horsepower should be invested in the design. Eventually a scientific advice strengthens your position (or at least, you get a more or less clear ‘no’ beforehand).

❝ ❝ What? Sorry, but I don’t get the point.

❝

❝ Further as you told about significance of the following statement in GL "This does not apply if the sampling period is 72 h or more and AUC(0-72h) is used instead of AUC(0-t)." is only to remind why it has been mentioned as ‘72 hrs or more’ as we generally truncate at 72 hrs only and even GL also specify the same? or used with different context?

I’m sorry, I still don’t understand what you mean. Maybe somebody else does.