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Table 5 Pharmacokinetic parameters of itraconazole in plasma and 90 % confidence interval of difference in the average values of logarithmic parameters

From: Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan

Parameters Number Reference product (Batch A) Test product (Batch B) Difference in the averate values after logarithmic conversion 90 % Confidence interval of difference in the average values of logarithmic parameters
Cmax (ng/mL) 28 41.5 (23.6) 64.2 (23.4) log(1.764) log(1.415) ~ log(2.198)
AUC48 (ng h/mL) 28 318 (166) 453 (161) log(1.592) log(1.317) ~ log(1.926)
  1. Data represents mean (SD). This test was performed by the innovator company