Part II - BEBAC ⢠Consultancy Services for Bioequivalence
Part II - BEBAC ⢠Consultancy Services for Bioequivalence
Part II - BEBAC ⢠Consultancy Services for Bioequivalence
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6/6 | Statistical Design and Analysis <strong>II</strong>IExample ABEL σ WR(WinNonlin)in<strong>for</strong>malife sciencesCalculate the scaled acceptance range based on theregulatory constant k (0.7601) and the limiting CV:[ ]U L e σk WR, =± ⋅σ WR 0.4628CV WR 0.4887L 0.7154U 1.3977CV2exp(WR1)<strong>Bioequivalence</strong> and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 2010WR= σ −30%
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