Bioequivalence and Bioavailability Forum

Hi wienui,

❝ I have a question regarding to the Bioequivalence (BE) study of IR tablets vs IR Film coated (F.C.) tablets.

❝

❝ if the BE study is done for the IR Tablets formulation and the manufacture want to register the IR Film coated tablets formulation, should he need to conduct a new BE study for this formulation?

❝ what I think is that the Pk behaviour for the two formulations ( especially the absorption process) will be totally different which could definitely different consequences of therapeutic effect. Please correct me if I'm wrong.

Since a film coat usually does not modify the release, this might be a situation where you can argue to use just dissolution. Show that the fc tablets behave like the ordinary tablet.