Bioequivalence and Bioavailability Forum

Hi Shuanghe,

❝ Didn't know it's a trilogy!

So do I. I don’t have the slightest intention to dive into validating NCA-algos. I think everybody should describe unambiguously in the protocol how it will be done (example). In this respect I concur with Sauter’s quote. In the majority (!) of reports I have seen the interval used for estimating λ_z is not given. If one wants to recalculate results it means a lot of trial and error. Especially how BQLs are treated deserves special attention. How are partial AUCs (or AUC_0–72) calculated if a sample is not taken exactly at the cut-off time? Does the software interpolate (and if yes, how)? t_75% (“plateau time” or “peak occupancy time 75%”; mandatory for MR in Russia) can be tricky. In the EU the peak-trough-fluctuation in BE should be calculated with C_ss,min at τ, whereas in BA (new drugs) C_ss,min within τ should be used. Only the latter is the standard in software.

BTW, if (if!) the algo is described in the protocol, recalculation is possible with a pocket calculator or even paper-pencil-brain. I don’t understand the agitation.

❝ So when can we expect "The Return of the King" (SCNR )? Don't keep us waiting.

Maybe it is like Patrick Rothfuss’ The Kingkiller Chronicle. Fans of fantasy fiction are waiting since 2011 for the third book.