Bioequivalence and Bioavailability Forum

Imbalanced cross-overs [Study Per­for­mance]

posted by Helmut  – Vienna, Austria, 2014-06-06 16:47 (4398 d 01:08 ago) – Posting: # 13038
Views: 22,546

Hi Khaoula,

❝ […] we collected the results of 15 subjects and we analyzed Kinetica without protocol for the management of dropouts

We recently have submitted a paper to the AAPS J (which currently is under review). It seems that Kinetica is not able to correctly deal with imbalanced studies. I strongly suggest to use another soft­ware (we got correct results in R, Phoenix/WinNonlin, EquivTest/PK, and SAS).

❝ we had abberants results: for Cmax CV = 0,03 % for hight variable drug …

I don’t understand what you mean here. The limit for HVDs/HVDPs is 30% CV of the reference obtained in a replicate design. CV_intra from a 2×2 serves only as a hint of a highly variable reference (since pooled from CV_WR and CV_WT).

❝ power: 50% …

A posteriori (aka post-hoc) power is irrelevant in BE. Stop calculating it.
Either the study passes, or not.

❝ with subject effect and subject/sequence effect

Subject effects are normal in a cross-over. It tells you that subjects differ – well, they should…

❝ […] the exclusion of subject N 15 have impact in the result of the study?

If evaluated by Kinetica, yes.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• randomization khaoula 2014-06-06 14:04 
  • Imbalanced cross-oversHelmut 2014-06-06 14:47
    • Imbalanced cross-overs khaoula 2014-06-06 16:03
      • CV 0.03%? Helmut 2014-06-07 13:52
      • Imbalanced cross-overs jag009 2014-06-09 15:36
        • Imbalanced cross-overs khaoula 2014-06-09 22:07
          • Bag full of bugs Helmut 2014-06-10 00:37
            • Randomisation? ElMaestro 2014-06-10 01:00
              • Randomisation? Helmut 2014-06-10 14:53
                • Randomisation? khaoula 2014-06-11 00:17
                  • Problems resolved? Helmut 2014-06-11 02:01
                    • Problems resolved? khaoula 2014-07-24 13:36
                      • corrected data in PHX/WNL Helmut 2014-07-27 01:37
          • Which version of Kinetica? Helmut 2014-06-11 19:51
            • Which version of Kinetica? khaoula 2014-06-12 00:41
            • Which version of Kinetica? khaoula 2014-07-25 00:49
              • adjusted means (aka LSMs) Helmut 2014-07-27 02:23
                • adjusted means (aka LSMs) khaoula 2014-08-25 21:41