Bioequivalence and Bioavailability Forum

Dear Sri,

It depends why the fasted study failed: if it failed because of a lack of power (not enough subjects), you would have to repeat the fasted study with more subjects and go also for a fed. So you may start with the fed study if you already have a protocol ready and approved by the Ethics Committee, with enough subjects planned. But if the fasted study failed because of differences between the two products and both a fasted and a fed study are required for approval, why go for the fed study ? The product will not be approved anyway. It would be unethical to run that second study for nothing. Better not loose time and money and put subjects at risk, rather go back to formulation development.

Regards
Ohlbe

Dear Friend,

It appears that from your question that the clinical phase of the fed study is already conducted. Well, in that case, on ethical grounds, you should proceed for analysis. Would like to know the results of fasting study and effect of food (if any) on the bioavailability of the product.

Thanks
biostar