Bioequivalence and Bioavailability Forum

Hi Tina,

❝ The test is an oily solution. How can dissolution tests be done with solution?

Sorry, my mistake. How is the formulation dosed? Do you have a metered dispenser? We once performed a comparative BA study (no BE!) of an oily solution (new formulation) vs. liquid filled capsules (US product) in the course of a European hybrid application. Too bad that the clinical study later on failed…

See also the section “Oral Solutions” in the IR GL:

In those cases where the test product is an oral solution which is intended to be bioequivalent to another immediate release oral dosage form, bioequivalence studies are required.

Even if you walk the route of “well established use” I can’t imagine that European regulators accept the application based on simply claiming “Our product – if dosed properly – contains the same amount of API like the IR tablet”.