Bioequivalence and Bioavailability Forum

Dear Sir,

Thanks for your esteemed reply.
Actually I wanted to submit this product to the USFDA.
You have clearly stated all the recommendations given by the USFDA and it is not very clear to me.
Sir I have one doubt that in case of fasting study the ratio is very good and it is around 100 for all the three parameters like AUCs and Cmax. But in case of the Fed study the ratio for AUCs are good and it is around 100 but the ratio of Cmax is very abrupt which is 130. Ideally if the ratio changes, it should change in all the parameters but in my case all the parameters are coming in range but the Cmax is only outside the range.
So I am wondering that is it a really the formulation problem or there is problem with the food given as breakfast and all other parameters which can likely effect the formulation release.
If I will reformulate and I will go to control the Release of the drug from the formulation in the fed condition as per the current data then it may likely impact the fasting data also which has a ratio of around 100 and it may come down to 90 also.
So sir please suggests me the best way as you have stated in the previous reply.