Bioequivalence and Bioavailability Forum

Dear BE-proff!

As usually one should be guided by the following rule: the sampling period should last not less than four times T_1/2 (when it less than 72). Practically it depends on many different factors and it is very important to know the pharmacokinetics from the previous studies. It is often can be analysed from the previously obtained mean pharmacokinetics curves.

There exists several approaches to estimate sufficient sampling period and adequate wash-out period. It can be represented by N times T_1/2 or MRT, where N is a numerical factor (usually 4 for sampling time and 5-6 for wash-out) or it may be obtained from the previously obtained standard deviation of T_1/2 or confidence interval (see this thread). As I understand numerical factors goes from the simplified model of logarithmical ellimination (like radioactive decay)... I will be grateful for some scientific articles dedicated to that topic.