(bioequivalence) requirements - BEBAC ⢠Consultancy Services for ...
(bioequivalence) requirements - BEBAC ⢠Consultancy Services for ...
(bioequivalence) requirements - BEBAC ⢠Consultancy Services for ...
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Practically meeting modified release BE (<strong>bioequivalence</strong>) <strong>requirements</strong>Single doseNCA (Methods)Unconventional parameters describingthe shape of profiles C max /AUC t 75% or POT-25 (Plateau Time: interval where C(t) ≥ 75% ofC max aka Peak Occupancy Time 25: time interval whereC(t) is within 25% of C max ) HVD or POT-50 (Half Value Duration, Peak OccupancyTime 50: time interval where C(t) ≥ 50% of C max ) Occupancy time, t ≥ MIC (time interval where C(t) is abovesome limiting concentration)in<strong>for</strong>malife sciencesInnovations in Modified Release | Evening Seminar | Berlin, 8 November 201117
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