Bioequivalence and Bioavailability Forum

Hi wxp,

❝ I agree with the way you mentioned. But it is time-consuming and needs more money.We did a 2×2 bioequivalance study of simvastin in 24 healthy volunteers.The intra-CV was >30%, which demonstrated that the sample size was not enough for a HV drug. I think if we can confirm a drug a HV drug before the study design, it will save a lot of time and money.

You are right to say if you could confirm that a drug is HV before the trial pivotal trial then things would be cheaper, faster, easier. But at the end of the day that's not really widely acceptable in countries like EU and USA. If company X has a formulation which in a study displayed HV (now I am talking a HV drug product) then this does not per se mean that a formulation with the same API from company Y is also displaying HV.
The topic has been thoroughly discussed at various levels at the agencies. I believe you need to show HV for your formulation if you want to claim HV for it.