Table 3.
Parameter | SWR | CVWR | Reference scaled average bioequivalence conclusion |
---|---|---|---|
log (Cmax) | 0.721 | 0.826 | RSABE applicable (SWR ≥ 0.294) |
log (AUClast) | 0.472 | 0.500 | RSABE applicable (SWR ≥ 0.294) |
log (AUC) | 0.406 | 0.424 | RSABE applicable (SWR ≥ 0.294) |
CVWR calculated for raw pharmacokinetic parameters, AUC area under the plasma concentration versus time, Cmax maximum plasma concentration observed, AUClast area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time