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Pharmacokinetic Analysis of BE DataSampling at Cmax50402–5 hrsarithmetic meangeometric meanmedian30k a = 0.182t lag = [0 | 2.5]201000 4 8 12 16 20 24Bioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201348 • 68
Pharmacokinetic Analysis of BE DataAnother Problem•EMA GL on BE (2010)•Section 4.1.8 Reasons for exclusion 1)• A subject with lack of any measurable concentrations oronly very low plasma concentrations for referencemedicinal product. A subject is considered to have verylow plasma concentrations if its AUC is less than 5% ofreference medicinal product geometric mean AUC (whichshould be calculated without inclusion of data from theoutlying subject). The exclusion of data […] will only beaccepted in exceptional cases and may question thevalidity of the trial.Remark: Only possible after unblinding!Bioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201349 • 68
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