Bioequivalence and Bioavailability Forum

Hi Raman,

❝ Thanks for your reply on tmax.

Welcome.

❝ In one study, we have drawn samples up to 96.00 hrs post dose. we have stated only Cmax and AUC(0 to t) as primary parameters for bioequivalence in our protocol. We have, mentioned AUC(0 to inf) as secondary parameter.

Fine, so far.
Was this an IR formulation? If yes, AUC_0–∞ is only required as a primary metric for the FDA. Not required according to the ICH M13A draft and it will be removed by the FDA once ICH M13A will be finalized.

❝ Sponsor wants AUC also to be tested for BE criteria.

Why didn’t the sponsor want that earlier, i.e., to be mentioned in the SAP as primary?

❝ Our statistician says, if we include tmax points for some subjects, it is passing. Shall we submit the AUC(0 to inf) data, (including tmax)?

Teach your statistician basic PK and the principles of NCA.
Furthermore, it’s cherry picking to try something to make any PK metric pass.