Bioequivalence and Bioavailability Forum

Hi sciguy,

❝ BA/BE is not the primary endpoint, more of a secondary objective to support early phase data to compare a combo drug vs each of the mono ingredients. They want to show no drug-drug interactions in the combo (ie: no difference vs. mono)

Well...this could come down to what you consider "pivotal" proof of whatever you wish to show. If the drug-drug interaction thing is only ancillary -which may actually be fair- then I guess co-variates could be explored.

Perhaps it could be an idea to define a tertiary objective, this being the investigation of relative BA using no covariates, or at least to also explore and present without those covariates.