Bioequivalence and Bioavailability Forum

❝ Pilot studies are good scientific practice – especially if your information are limited and based on literature only. A nice justification is given in FDA’s guidance ( Section III.A.2).

Hello Mr. Helmut

Well, this is what many researchers still believe to be correctly. I understand that it is necessary to develop predictive ways to know if the main study will be approved or not without spending much money . Unfortunately, "there is no other way to made a cake without breaking eggs" . That is, if we do a pilot study and the high variability is found with a low N (intra-subject in the case of a crossover trial), then we have a study with little power to draw valid conclusions in respect of bioequivalence. Recently I did a data mining in my database (I've done many studies over 10 years experience) and the pattern found was that the ratio's of Cmax and AUC is not stable for studies with underpowered. Please also do this analysis in your bank you will be surprised ... If you want to discuss more about it I'll be happy ...