Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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6/6 | Statistical Design and Analysis IIIHVDs/HVDPsEU GL on BE (2010)CV% L% U%30 80.00 125.0032 78.87 126.7934 77.77 128.5836 76.69 130.3938 75.64 132.2040 74.61 134.0242 73.61 135.8544 72.63 137.6846 71.68 139.5248 70.74 141.3650 69.83 143.20Acceptance limits [% Ref.]15014013012011010090807060EU SABE20 30 40 50 60informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 2010µT/µR36 • 68
6/6 | Statistical Design and Analysis IIIHVDs/HVDPsinformalife sciencesTotfalushi et al. (2009), Fig. 3Simulated (n=10000) three-period replicate design studies (TRT-RTR) in 36 subjects;GMR restriction 0.80–1.25. (a) CV=35%, (b) CV=45%, (c) CV=55%.ABE: Conventional Average Bioequivalence, SABE: Scaled Average Bioequivalence,0.76: EU criterion, 0.89: FDA criterion.Bioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201037 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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Part II - BEBAC â¢ Consultancy Services for Bioequivalence