Bioequivalence and Bioavailability Forum

Dear Mei San

During the development of a medicinal product the dissolution test is used as a tool to identify formulation factors that are influencing and may have a crucial effect on the bioavailability of the drug. You can argue that in the event that the results of comparative in vitro dissolution of the biobatches do not reflect bioequivalence as demonstrated in vivo the latter prevails. However, possible reasons for the discrepancy should be addressed and justified and honestly, I wouldn't try a study if comparative in vitro dissolution shows such demoralizing results.
As you learned so far in your case BE will be tricky and variability will be high. And then you will start with such a formulation? Forget it!