Bioequivalence and Bioavailability Forum

Dear ElMaestro!

Great ideas!
But I guess it’s even worse. The half-life of this drug is reported in the literature with 1–4 hours. The CRO has a pretty good analytical method – with a worse LLOQ you wouldn’t see the slower phase(s). He/she/it didn’t run a script, since in some subjects with lower concentrations he/she/it was happy with just the last 3–4 points. I think that he/she/it tried to tweak the results in such a way that results are not too far away from the literature.
According to the report (54 profiles): x̃ 4.61 h (2.49 – 8.34 h), while my eyeballing PK gives 5.05 h (2.78 – 8.34 h). Since the CRO had no problems with extrapolations (C_last >LLOQ in all pro­files; max. residual AUC 6.2%) probably he/she/it wanted to avoid trouble in reporting a ‘long’ t_½…
Perhaps a case of anticipatory obedience (vorauseilender Gehorsam). No, the CRO was not in Germany).

❝ Probably the wise guy has already been promoted as we speak?

Oh goodness!