Transcription of Bioavailability / Bioequivalence - bebac.at
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Bioavailability / Bioequivalence - bebac.at
Selection of CROs Selection of a Reference Product Metrics (AUC, Cmax/tmax, Shape of Profile) Acceptance Ranges ( and beyond) Sample Size Planning (Literature References, Pilot Studies) Steps in bioanalytical Validation (Validation Plan, Pre-Study Validation, In-Study Validation) Study Designs Protocol Issues Evaluation of Studies Advanced Topics Avoiding PitfallsBioavailability / Bioequivalence1 Study Designs Single Dose / Multiple Dose Standard 2 2 Cross-over Parallel Groups for more than 2 FormulationsBioavailability / Bioequivalence2 Study Designs (Single Dose / Multiple Dose) Single Dose recommended in most international Guidelines, but steady-state studies: may be required: in the case of dose- or time-dependent pharmacokinetics, for some modified release products (+ Single Dose BE).
Study Designs Single Dose / Multiple Dose Standard 2×2 Cross-over Parallel Groups for more than 2 Formulations Bioavailability / Bioequivalence 2 Study Designs (Single Dose / …
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