Bioequivalence and Bioavailability Forum

Dear all,

We are going to conduct a study with the combination of drug products for the submission of Canada. As per the Canada Guidelings (Report C Combination drug products) the following parameters must be reported.

1. The ratios of the concentrations of each drug and/or metabolites at the t_max as determined for each drug.
2. The ratios of the concentrations of the drugs at the last time point of the most commonly used dosing interval (i.e., at t_x);
3. The ratios of the AUCt_x of the drugs and/or metabolites.

Now my doubts are
1. How to calculate the ratios of the concentrations at t_x?
2. What is meant by t_x?
3. How to calculate the ratios of the AUCt_x for test and reference products?

Kindly, clarify my doubts.

Thanks in advance.

--
Eidit: Category changed. [Helmut]