Bioequivalence and Bioavailability Forum

Dear MGR!

❝ ... if the confidence interval limit of Cmax (Fed study) is increased when compared to the fasting study.

What do you mean by 'the confidence limit is increased'?
Do you mean, the upper CL of C_max in the fed study is higher than the upper CL of C_max in the fasting study - while the PE/GMR (point estimate / geometric mean ratio) is essentially the same?
If yes, the CV_intra obviously is higher, which can be caused by numerous reasons:

• smaller sample size,
  
• pure chance, or
  
• 'true' higher variability in the fed state.

❝ From this can we say that the absorption of Cmax is high when compared to Reference drug.

Just have a look at the point estimate.

❝ But according to the label and literature "In fed conditions the rate and absorption of Cmax will be increased when compared to fasting conditions" but in our study the mean Cmax is decreased when compared to the fasting study, as the mean Cmax of reference is also decreased and less than Test mean Cmax.

Attention: the innovator has done a food interaction study (i.e, a 2x2 cross-over study of his procuct in fed vs fasting conditions), whereas you are comparing results from two studies; results may differ just by chance!

❝ From this point can we consider that the rate and absorption of Test is better than Reference drug?

Now I'm even more confused. Would you please come up with some data from both studies (PE and 90% CIs).