Pharmacokinetic Analysis of BE Data - BEBAC â¢ Consultancy ...

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Pharmacokinetic Analysis of BE DataNCA (Problems)10080ReferenceTestLLOQ = 10concentration6040C 72 estimated from C 24 –C 482000 12 24 36 48 60 72timeBioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201340 • 68
Pharmacokinetic Analysis of BE DataNCA (Problems)•Missing values II•Last value of T missing(e.g., vial broken)• Estimating the missing valuefrom elimination phase.AUC 72* T = 2835AUC 72 R = 2984T/R = 95% ‣ Not available in software‣ Regulatory acceptance ±time00.250.500.751.001.523469121624364872ReferenceconcBLQAUC 0-t028.57 448.57 1362.50 2772.15 4483.26 8388.14 12690.14 21588.70 30484.07 47777.11 71970.71 94063.00 120850.00 166035.36 217225.00 253412.50 2984concBLQTestAUC 0-t027.14 346.14 1359.38 2668.55 4279.10 7983.73 11985.63 20484.26 28979.86 45373.25 68367.18 89359.85 114747.50 157733.59 206323.75 2407*11.88 *2835Bioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201341 • 68
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