Bioequivalence and Bioavailability Forum

Dear Samaya,

❝ Is there any possibility to get through by any means or study to be repeated?

By any means??
Well, your GMRs or T/R ratios itself are on lower side 84% (79.89-89%) and 86% (83-90%) so I don’t think that repeat study is going to be that helpful.

❝ Or we should go ahead with the reformulation??

From the Cmax and AUC data it is very clear that the rate of release and extent both are lesser. So the best approach should be to find a discriminatory dissolution condition and then plan your activities accordingly.

I assume it to be a BCS Class II molecule so why don’t you look into the reference characterization first (use of specific particle size range/use of surfactant etc.) along with API characterization (different polymorph different solubility).
Also is there any information available on saturation metabolism of the molecule? That might also provide you idea about what went wrong.

Hope this will give you some leads.