Bioequivalence and Bioavailability Forum

Dear Martin!

❝ ad) values > LLOQ or beginning <LLOQ: I deal with large molecule drugs – I have only measured values or values below LOQ (limit of quantification) I do not have experience with a “fuzzy range”.

Eventually my question was misunderstandable. Let me give examples to make it clear.
Beginning values <LLOQ:
t=0h, c=0; t=0.25h c= <LLOQ; t=0.5h, c=<LLOQ;t=1h, c=10
Do you then take c <LLOQ as missing?

Intermediate values <LLOQ:
t=12h, c=15; t=18h c= <LLOQ; t=24h, c=2;
Do you then take c <LLOQ as missing?

❝ PS.: what do you think on providing boxplots per time point instead of means?

This is a good suggestion, I think, it calls for median as the mean function.
But I think it is very unusual for BE reports I have seen so far.
My sponsors always have difficulties if Box-plots are provided (until now for the PK parameters). The plots need some deeper understanding in statistics compared to mean plots which is not always there.