Bioequivalence and Bioavailability Forum

Dear Dr. Dan,

thank you so much for your reply.
sorry i forgot to include example in my previous post.

ok, let me give you a situation that relates to my previous question: e.g Losartan potassium only dissolves in pH around 6.8 (according to the manufacturer) and fails to show similar dissolution profile in more acidic pH. so they can only prove dissolution similarity in one medium. is this acceptable? or do we need to advice the manufacturer to add surfactant in their dissolution medium?

i also have another question. for Simvastatin, according to USFDA both parent compound and active metabolite should be analyze and reported but bioequivalence determination is based on the result of parent compound. we received a lot of report whereby parent failed to show BE but they use results of active metabolite to prove that the product is bioequivalent. is that acceptable? in your opinion, what is the justification of this condition?

hope to hear from you soon.

TQ!!