Bioequivalence and Bioavailability Forum

Dear Jo!

❝ I would like to know if Thermokinetica (last version of Innaphase Corp.) is an appropriate pharmacokinetic software to be used in the analysis of a bioequivalence study with replicate design.

I'm not sure what you mean by 'last version of Innaphase Corp.' InnaPhase was acquired by Thermo Electron (now Thermo Fisher Scientific) in 2004. InnaPhase's last Version of Kinetica was 4.2 (or 2000? Don't know. Have it somewhere on an old machine.) The current version (2008) is 5.0.10.

At least it is possible to analyse a replicate design for Average Bioequivalence. Maybe results needed for PBE/IBE or scaling are somewhere hidden in the output - but I'm not an expert in Kinetica's user interface...
Kinetica has only two settings for the acceptance range, namely [FDA 0.80-1.25] and [Europe 0.70-1.43]. Bad luck if you have an NTID and want to go with 0.90-1.11 or even Canada's asymetric ones (0.90-1.12).

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Edit: Compared a replicate dataset (RTR-TRT) to WinNonlin. Results differed. Kinetica's documentation is - politely speaking - not exhaustive. Looking at the ANOVA table I wouldn't trust the results!