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12/1/2002

7:59

A.9.9.5.2. Treatment B: Sandimmun Neoral Solution

■ The measured peak plasma concentrations Cmax ranged from 126.4 to 398.1 ng/mL with a mean Cmax value of 271.7+80.2 ng/mL.

■ The AUC0_,t values ranged from 213.650 to 1106.600 ng hr/mL with a mean AUC0_, t value of 577.804 + 213.396 ng hr/mL.

■ The AUCo-, « values ranged from 254.107 to 1189.230 ng hr/mL with a mean AUCo-, t value of 621.125 ± 230.127 ng hr/mL.

■ The time imax to reach peak plasma concentration ranged from 0.75 to 1.75 hours with a mean imax value of 1.35 + 0.24 hours.

■ The ratio (AUC0^ t/AUC0^ » )% ranged from 83.86% to 98.05% with a meanvalue of (AUC0^ J AUC0- » )% of 92.96 ± 3.44%.

A.9.9.5.3. Results of ANOVA

ANOVA of log-transformed data for Cmax, AUC0 _, t and AUC0 _, and for the untransformed data for Cmax, AUC0->■t, AUC0->■», t(i/2)e, Ke, and imax demonstrated that sequence effect, product effect, and period effect for all bioequivalence metrics did not significantly influence the outcome of the study. The cyclosporine results from the ANOVA table for each bioequivalence metric are located in Table C.10. Further details may be found in Appendix 4 of this section "Statistical Outputs."

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