Bioequivalence and Bioavailability Forum

Dear Kaushalesh and YT,

❝ Indeed! If your study staff knew that this is a protocol deviation then

❝ what is the point to continue with that particular subject.

I wouldn't be as strict as you. Some protocol deviations are minor and do not justify the exclusion of the subject. Whenever a protocol deviation occurs the investigator has to decide whether is is major or minor, and whether the subject can continue or not. In this case the investigator decided to continue. You may disagree with the decision, but it was taken.

❝ Any deviation in the protocol is a deviation and that is an abstract fact.

❝ so you shouldn't try to hide or modify the fact.

Nobody suggested to hide the fact. Deviations should indeed be reported in the sudy report.

❝ The QA : "If you think there are little effect on absorption, why you

❝ write it down in the protocol............."

Because everybody uses standard protocols, with very little adaptation to the drug studied. Some criteria may be critical for one drug, but of little relevance for the next. YT, in the case of your drug, is there anything in the literature on the influence of posture ? This will help decide whether the protocol deviation is major or not.

❝ The QA with Mr.Statistician said : "Of course, we should drop him because

❝ this is protocol deviation. Why should we keep him?"

Problem: we usually don't plan "per protocol" and ITT populations in BE protocols...

Whatever you decide: take the decision before you analyse the samples from this subject.

Regards
Ohlbe