Bioequivalence and Bioavailability Forum

Dear Pavan!

The statement about data mining in this post applies here also.

❝ Suppose we got 3 consecutive missing values in either Elimination Phase or

❝ Absorption Phase or At Initial Stage.

What do you mean by 'Inital Stage'?

❝ What is the action we need to take? ie to eliminate the subject from the

❝ analysis or to do analysis as it is.

Three values in the elimination phase simply are too many for imputation - at least according to my SOP.
Using AUC_t for that subject would bias the T/R-ratio. It does not make sense to compare AUC₁₆ of the test with AUC₄₈ of the reference. One option would be to truncate AUCs at last time point you have data for both formulations in that subject. Intersubject CV will increase, but T/R should be unbiased.

Missing values in the absorption phase are even more tricky. You may keep the subject e.g., for gastric-resistant formulations (lag-times), if after the missing values you still have the absorption phase well-defined. If you see a 'first-time' C_max I think you have to exclude the subject.