Bioequivalence and Bioavailability Forum

Dear all,

We are planning to conduct a bioequivalence study with sufficient number of subjects (N=50). After clinical phase, we will complete bioanalysis for first 50% of subjects. Then, we do pharmacokinetic and statistical analysis for the 50% data (N=25 subjects).

If CV is less and ratios is close to but not within the limits of 80-125%, then we want to continue the study with bioanalysis of remaining 50% subjects (N=25) and construct 90% CI at alpha=5% for entire data (N=50).

With the first 50% data, if CV is high and ratios are very much beyond the limits of 80-125%, then we want to stop the bioanalysis and study.
Whether this procedure is acceptable or not?

Please clarify.

Thanks&Regards
Kotu