Bioequivalence and Bioavailability Forum

» We have given concomitant medication to subjects during clinical phase and the route of administration was topical, local (eye drops), IV, IM.
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» Can anyone suggest me if it is required to include these medications in concomitant medication experiment if the route of administration is other than oral (e.g. IV, topical, eye drops) during clinical phase?

Not sure if this answers your question(I think so but..):
Why not? For both safety and bioanalytical reasons.

J

Dear Qualityassurance,

» Can anyone suggest me if it is required to include these medications in concomitant medication experiment if the route of administration is other than oral (e.g. IV, topical, eye drops) during clinical phase?

I would say it depends on the bioavailability of these products when administered by these routes. For IV, no discussion (at least, if there is an active substance - don't bother about saline or glucose). But for a topical administration the answer is likely that there is no point.

Dear qualityassurance
In case of a bioequivalence study, it also depends on whether the concomitant medication was
given obligatory to all subjects or was taken accidentally by one or maybe more subjects. In the first case, the effect for the test and the reference formulation would be the same and you do not need to argue. Otherwise, a detailed risk analysis should be carried out, which describes the estimated PK effects of the concomitant medication on the bioequivalence decision. If only a view subjects are affected a sensitivity analysis could be carried out.
I hope this helps.