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. 2020 May 16;37(6):2696–2709. doi: 10.1007/s12325-020-01369-z

Table 4.

Formulation effect on Cmax, AUClast, and AUC for acetylsalicylic acid in test versus reference

Parameter Estimate Acetylsalicylic acid* Clopidogrel#
95% CI for (μT − µR)2 – θσWR2 Estimate 90% CI
Cmax 1.19 − 0.30 1.11 1.05–1.18
AUClast 1.09 − 0.14 0.95 0.91–0.99
AUC 1.04 − 0.10 0.96 0.92–1.00

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

*Point estimates of formulation ratios and upper one-sided 95% confidence interval for the reference scaled average bioequivalence metrics (SWR ≥ 0.294); upper 95% CI for (μT − µR)2 − θσWR2θ = [ln (1.25)/σ0]2 with σ0 = 0.250 corresponding to a regulatory constant

#Point estimates of formulation ratios with 90% CIs using average bioequivalence analysis