Bioequivalence and Bioavailability Forum

Hii Helmut

In USFDA submissions we have successfully conducted BE study on 20 mg strength(higher) as per FDA draft guidance under fasting & Fed conditions and Appling for Waiver request of in vivo testing: 2.5 mg, 10 mg and 15 mg strengths based on
(i) acceptable BE studies on the 20 mg strength,
(ii) proportional similarity across all strengths, and
(iii)acceptable in vitro dissolution testing of all strengths
However for 2.5 mg strength we are failed to submit in vitro dissolution data.
so-
Is we need to Conduct in vivo BE study for 2.5 mg Strength?

what is study condition for study either Fasting or Fed or Both fasting & Fed for 2.5 mg strength?

Some Notes are-
Our formulation is Immediate release Tablet formulation.

Drug demonstrates a steep exposure-response relationship for both efficacy and safety.

pharmacokinetics are approximately linear up to about 15 mg once daily in fasting state.
Under fed conditions Drug 10 mg, 15 mg and 20 mg tablets demonstrated dose-proportionality.

At higher doses Drug displays dissolution limited absorption with decreased bioavailability and decreased absorption rate with increased dose.


Thanks
Vishal S

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