Bioequivalence and Bioavailability Forum

Dear miLi!

❝ I am working on a old bioavailability study.

Sincere condolences.

❝ there is only 7 sample times. The first analysis has been done with incremental troncated AUC.

Interesting. I hope the protocol did state one metric as the main parameter - otherwise you will run into multiplicity issues.

❝ I have calculated AUCinf but the problem is that 1/3 of Tmax is at the last or the last but one sample time.

I guess you mean ⅓ of C_max?

❝ The data even give some (1/6!!) negative Ke!!!

Do I get you right: you 'see' increasing values in ¹/₆ of subjects?

❝ It is not a problem in my program because you can verify it on graph.

What program are you using? K_el by definition is positive (denoting a transfer from the central compartment); all programs specialized in NCA PK analysis would come up with an error message.

❝ My question is : According to the study report, there has been no problem to perform the analysis on this data.

There's an American phrase for it: 'Lights on, nobody at home.'

❝ But, I wonder about the (poor ?) credit that we can give to the results of this first analysis.

Forget it (sorry).

❝ Sorry for my poor english.

No problem. If I misunderstood you, please correct me.