Pharmacokinetic Analysis of BE Data - BEBAC ⢠Consultancy ...
Pharmacokinetic Analysis of BE Data - BEBAC ⢠Consultancy ...
Pharmacokinetic Analysis of BE Data - BEBAC ⢠Consultancy ...
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<strong>Pharmacokinetic</strong> <strong>Analysis</strong> <strong>of</strong> <strong>BE</strong> <strong>Data</strong>NCA (Problems)•Missing values II•Values below the lowerlimit <strong>of</strong> quantitation (LLOQ)• Example as before,but LLOQ = 12.5 (instead 10)AUC 72 : T = ?, R = 2984T/R = ?AUC 48 : T = 2407, R = 2534T/R = 95% AUC all : T = 2692, R = 2984T/R = 90.22% biased!AUC 72* : T = ?, R = 2984T/R = ?time24364872time24364872time24364872Referenceconc50.00AUC 0-t166035.36 217225.00 253412.50 2984Referenceconc50.00AUC 0-t166035.36 217225.00 253412.50 2984Referenceconc50.00AUC 0-t166035.36 217225.00 253412.50 2984conc47.50TestAUC 0-t157733.59 206323.75 2407BLQ NATestconc47.50AUC 0-t157733.59 206323.75 2407= *0 2692Testconc47.50AUC 0-t157733.59 206323.75 2407*11.88 NABioequivalence Assessment <strong>of</strong> Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201342 • 68
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