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Practically meeting modified release BE (bioequivalence) requirementsSingle doseNCA (Methods)Method of estimation of λ z stated in protocol! One-compartment model: TTT-method *(Two times t max to t z ) Maximum adjusted R² (Phoenix/WinNonlin, Kinetica)22 (1 − R ) ⋅( n −1)WinNonlin ≤5.3:Radj= 1−n − 2 Multi-compartment models: starting point = last inflection Minimum AIC AIC = n ⋅ ln(2 ⋅ π ) + 1 + n ⋅ ln( RSS n) + 2⋅p[ ] Visual inspection of fit mandatory!C max includedPhoenix/WNL ≥6.0: C max excludedinformalife sciences* Scheerans C, Derendorf H and C KloftProposal for a Standardised Identification of the Mono-Exponential Terminal Phasefor Orally Administered DrugsBiopharm Drug Dispos 29, 145–157 (2008)Innovations in Modified Release | Evening Seminar | Berlin, 8 November 201114
Practically meeting modified release BE (bioequivalence) requirementsNCA (Methods)100plasma profile (linear scale)80concentration604020informalife sciences00 4 8 12 16 20 24timeInnovations in Modified Release | Evening Seminar | Berlin, 8 November 201115
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