(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>NCA (example)MR (IR+DR) methylphenidate 60 mg o.a.d. fed100concentration [ng/mL]101Estimation of AUC τ andC min if sample at t=τ ismissingC z 0.917C min 0.131 (1)C min 0.137 (2)0.2in<strong>for</strong>malife sciences94 96 98 100 104 108 112 120time [h]Innovations in Modified Release | Evening Seminar | Berlin, 8 November 201149
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