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Pharmacokinetic Analysis of BE DataNCA (Methods)•Multiple dose•Calculation of AUC τ (dosage interval τ );AUC ss,24h if more than o.a.d. and chronopharmacologicalvariation)•No extrapolation!•C ss,max and C ss,min directly from profile•Peak-Trough-Fluctuation: (C ss,max –C ss,min )/C ss,av ,where C ss,av = AUC τ /τ•Swing: (C ss,max –C ss,min )/C ss,minBioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201330 • 68
Pharmacokinetic Analysis of BE Data•Multiple doseNCA (Methods)•Assessment whether steady state is reached (ina linear PK system: AUC τ = AUC ∞ )• No recommendations in GLs (except EU/US Veterinary)• Not required according to comments to EMA’s BE-GL• MANOVA-model (sometimes in CAN, rarely used)• t-test of last two pre-dose concentrations• Hotelling’s T²• Linear regression of last three pre-dose concentrations,individually for each subject/treatment• Only the last method allows the exclusion of subjects beingnot in stead state. Other methods give only a yes|no result!Bioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201331 • 68
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