Bioequivalence and Bioavailability Forum

Hi Rabbaska,

❝ time conc


❝  0.0 0.00
❝  0.5 0.27
❝  1.0 0.36
❝  2.0 0.42
❝  3.0 0.60
❝  4.0 0.70
❝  6.0 0.49

Your C_max is at four hours and you have only one descending concentration. Even if you would have sampled longer, it is debatable* whether the concentration at six hours should be used (might still be influenced by absorption/distribution). bear requires at least three data points to estimate λ_z.

❝ … and what to do with it?

What does you protocol say? Generally at least three samples are required. Up to you.

❝ Is it something with file (I tried to upload the same data with .RData, .csv, .txt and other formats, all in vane) or bear does not like the data?

The latter.

❝ For sure, my friend performed the analysis in Phoenix and had the result.

Not with the default setting. Of course he/she could have forced PHX to use the last two time points, but

• IMHO, it does not make sense.
  
• Would you prefer to report an extrapolated AUC which is 48% of AUC_∞?

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• Scheerans C, Derendorf H, Kloft C. Proposal for a Standardised Identification of the Mono-Exponential Terminal Phase for Orally Administered Drugs. Biopharm Drug Dispos. 2008;29(3):145–57.