Bioequivalence and Bioavailability Forum

Hi RK,

❝ […] two timepoints - Predose and one postdose (0-24 hrs post dose). Is it possible to estimate the PK parameters.

I assume your drug is not an endogenous compound. Therefore, you could only calculate Ae₂₄. Since you have no previous samples (in the absorption phase) you have no clue whether excretion is – more or less – complete or not. Doesn’t make any sense.

❝ What is the minimum number of timepoints required for urine PK estimation.

You have to calculate the maximum excretion rate as well – which is tricky. In my experience the minimum are ~six samples. Since the rate is rather difficult to calculate from urine data, EMA wants to see C_max from plasma anyway.