Bioequivalence and Bioavailability Forum

Thanks Helmut,

I back-computed the intra-CV from the single dose interaction study and it was 13-14%. I decided to go with 20% CV as the basis for my sample size estimation. I hope that's not an overkill...

Another question, for truncated AUC0-72 hours, what is your experience in terms of setting the limit for 72 hr blood draw time deviation? The drug has a half-life of 20-30 hours. The clinic allows the subjects to return for the 72 hour return blood draw with a +4 hour time limit (i.e, if they come back after 76 hours then they will not collect it).

Is that a bit too late? I would either set the limit to 1 hour or keep the subject for 72 hours in house.

Thanks

John