Bioequivalence and Bioavailability Forum

Hi Helmut
Thanks for your reply

❝ Actually \(\lim_{x \to 0}\log(x)\small{=-\infty}\) and therefore, if we ask to calculate log(0) we will get -Inf as the – mathematically correct – answer. Nice, though not helpful if we want to use such a value in further calculations. Only by convention we say that \(\log(0)\) is ‘undefined’. There­fore, any \(\small{x\leq0}\) is either excluded in software or throws an error. There is no way to get around it.

❝ You could only perform a sensitivity analysis setting all BQLs to say, LLOQ/2. Unless the study is not very large and the CV very small, quite likely it would fail.

as we use SAS im calculation, are there any way to calculate with SAS, in addition what if we assumed that lin(PK) equal zero, is this applicable ? another question could we consider these values as 5% of loq not LLOQ/2 as the observed results around 5-10 % of LLQ

Thanks