Statistical Evaluation of Bioequivalence Studies - BEBAC ...
Statistical Evaluation of Bioequivalence Studies - BEBAC ...
Statistical Evaluation of Bioequivalence Studies - BEBAC ...
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Group Sequential Design± EU• Personal Experience:‣ <strong>Evaluation</strong> <strong>of</strong> first part by an independent statistician(CV only!), performance <strong>of</strong> a second part, evaluation<strong>of</strong> pooled data without α-adjustment – 90 % CI(2 cases Germany, 1 case France).‣ May be a reasonable approach, because Add onDesigns are in practice in Canada (since 1991), andJapan (since at least 1997).Dissolution Testing, Bioavailability & <strong>Bioequivalence</strong> | Budapest, 24 May 2007 26
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