Bioequivalence and Bioavailability Forum

Dear HS,

according to your post i hav some doubts, please guide me...

❝ Generally, three successive CMIN values should be provided to verify that steady-state conditions have been achieved.

Here, is it three successive CMIN values means last Three pre dose values ?

❝ Although CMIN most frequently occurs immediately prior to the next successive dose, situations do occur with CMIN observed subsequent to dosing.

But Cmin occurs in between Last dose and AUC_tau then how above statement is possible ?

❝ To determine a steady state concentration, the CMIN values should be regressed over time and the resultant slope should be tested for its difference from zero.

If I have performed ANOVA (using last three pre dose values (time point x, y, z) and result (p-value=0.3241) shows there is no significant difference between three pre dose values.
And for same study I have regressed Cmin over Tmin and resultant slope tested for its difference from zero and result shows (p-value = 0.0219), slope is different from zero.

From above both result shall I conclude that steady state achieved after (or at) time point x?


Thanks and Regards,

Ram