The pharmacokinetic variables area under the plasma concentration curve (AUC), maximum plasma level (Cmax), and time of maximum plasma level (Tmax) were calculated for each subject from plasma concentrations assayed at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7 and 8 hours post dosing on the fourth (last) day of each treatment period. The pharmacokinetic calculations were performed for each component of the combination drug and are present in Table 2.

• Are the manufacturing processes, A and B, equivalent as evaluated by AUC, Cmax, and Tmax?
  (Primary consideration is usually given to AUC but since this is a controlled release formulation, Cmax and Tmax will take a close second in importance.)
• Should the components be evaluated separately or combined?