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Practically meeting modified release BE (bioequivalence) requirementsNCA (alternative metrics)MR valproic acid 500 mg o.a.d. fasting (n=20)informalife sciencesmetricAUC τC maxC minMRT τ%PTFSwingpAUCFAUC95.6%94.0%94.1%98.6%76.4%67.9%87.7%73.0%90% CI105.9%102.3%109.3%101.7%106.1%104.3%122.3%100.5%Innovations in Modified Release | Evening Seminar | Berlin, 8 November 2011metric median BE criterionf 1 11.38 ≤20ξ 1 0.05535 ≤0.1ξ 2 0.06227 ≤0.1ξ 3 0.06660 ≤0.1ψ 0.7433 ≤1ρ 1.120 ≤1.4ρ m 0.1196 ≤0.35δ a 0.1086 ≤0.27δ s 0.01906 ≤0.102MARD 0.1218 ≤0.2MARD w1 0.1187 ≤0.2MARD w2 0.1668 ≤0.2PCA 0.8951 ≥0.8230
Practically meeting modified release BE (bioequivalence) requirementsNCA (alternative metrics)MR theophylline 400 mg o.a.d. fasting (n=24)concentration [µg/ml]2520151050geometric means (n=24)testreference0 4 8 12 16 20 24time [h]co n ce n tra tio n [µ g /ml ]co n ce n tra tio n [µ g /ml ]2 52 01 51 0502 52 01 51 050 4 8 1 2 1 6 2 0 2 4ti m e [h ]00 4 8 1 2 1 6 2 0 2 4ti m e [h ]informalife sciencesInnovations in Modified Release | Evening Seminar | Berlin, 8 November 201131
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