Bioequivalence and Bioavailability Forum

Thanks for Your reply,

Now coming to my study design it is a Anti diabetic drug, dose response cum bioequivalence study. As per the study design it is a four treatment four period four sequence crossover study.

We will administer three different doses of reference (25mg, 50mg and 75mg) and a test drug (50mg) in different periods. And each period has two days. On day1 we will be administering 75g sucrose solution and on day2 we will be administering one of the study formulation along with sucrose solution and collect the blood samples. From these samples we are measuring the glucose content. From these measured glucose contents we are going to calculate three parameters Cmax (Max observed glucose content), AUEC0-2 and AUEC0-4 for day1 and day2 separately and calculate the difference of these parameters (Day1-Day2).

And now how can we identify the minimum effective dose (reference) for comparing the test product for bioequivalence.

As per the study design we have to apply ANCOVA on the ln-transformed differences of the above calculated parameters (Cmaxdiff, AUCE0-2diff & AUEC0-4diff) by considering the day1 parameters as covariates for determination of minimum effective dose (Reference 25mg/50mg/75mg).


Can you please suggest me what is the procedure for determination of minimum effective dose and how can we determine the homogeneity of slopes between formulations.

Pls do guide me with relevant literature if possible.

Regards,
DIXIT.