Bioequivalence and Bioavailability Forum

Hi ElMaestro,

❝ We could put anything into the last two samples like sample 21 = "sample 20 diluted x.95" and sample 22 ="sample 20 diluted x.90" or something.

Who is “we”? The clinical staff, right? Then they would have to harvest 3times the usual volume of sample 20 and have some blank matrix at hand.

❝ The smart analyst you refer to may then look at the two profiles to check if the Cmax occurs on sample X in one series and on sample Y in another and try to work out something from the design.

Correct.

❝ Perhaps one should make an effort ascertain that the sample number that corresponds to Cmax occurs at the same spot in the two series.

Oh dear!

❝ […] how could one rock-solidly assure analyst-blindedness in those trials, in your opinion?

No idea.
BTW, we had never fun with FIM trials. Verum generally a bolus or fast infusion. We always crossed fingers to have no concentrations >LLOQ in some of the profiles (guess, which ones). Blinded for treatment? Gimme a break.