Bioequivalence and Bioavailability Forum

Hi John,

❝ Can I get a copy too?

Check your inbox. But it is real crap – not worth the additional analytical efforts.

If you still want to dive in I would suggest to try it with a reasonable number of your past studies. Calculate the means of individual concentrations / treatment and their AUCs, the ratio, and check according to the table (based on the CV you used in planning the study) whether you would have stopped the study or not. Good luck – and tell us how many false positives you observed…

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PS: In the last century when we applied this procedure a couple of times (Sponsor’s wish  – “Considerable cost savings” in the title!) we faced some obstacles. When taking aliquots the accuracy of the pipetting is not important – as long as it is done precisely. We decided not to leave this on the shoulders of the clinical staff, but delegated an analyst. But: That’s work unblinded for treatment. We had to set up an SOP guaranteeing that this analyst would not analyze the biosamples later on. I’m not sure whether inspectors would believe (!) that she didn’t memorize the randomization scheme and tell it to her colleagues… Trouble on the way.
PPS: What’s the percentage of your studies without a single drop-out?