Bioequivalence and Bioavailability Forum

Dear Pravin!

❝ Any one will clarify me about Dosage form proportionality studies, its criteria, regulatory requirment and statistical methods for the same.

Please search the forum in the future.
I don’t know of any regulatory requirements for dose-prop. studies (except that you have to provide data for NCEs in NDAs). If you want to apply for a dose-proportionality biowaiver in the context of BE, EMA accepts ±25% of dose-normalized AUCs from the literature (GL Section 4.1.6).
If you want to set up a confirmatory study: Cross-over of ≥3 strengths and define one – commonly the highest – strength as the reference. Assess CIs of dose-normalized AUCs. In my (European) experience regulators want a to see a multiplicity adjustment in order to keep the overall patient’s risk at ≤5%. Maybe this lecture helps. See also slides 100–101 of another lecture about multiplicity.