Design and analysis of bioavailability and bioequivalence studies / Shein-Chung Chow, Jen-pei Liu
By: Chow, Shein-Chung
Contributor(s): Liu, Jen-pei
Material type:
Item type | Current location | Call number | Status | Date due | Barcode |
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Centeral Library Second Floor - Pharmacy | 615.7 C.H.D 2009 (Browse shelf) | Available | 12742-1 |
Includes bibliographical references (p. 647-667) and index
Design of bioavailability studies -- Statistical inferences for effects from a standard 2x2 crossover design -- Statistical methods for average bioequivalence -- Power and sample size determination -- Transformation and analysis of individual subject ratios -- Assessment of inter- and intra-subject variabilities -- Assumptions of outlier detection for average bioequivalence -- Optimal crossover designs for two formulations for average bioequivalence -- Assessment of bioequivalence for more than two formulations -- Population and individual bioequivalence -- Statistical procedures for assessment of population and individual bioequivalence -- Assessment of bioequivalence for drugs with negligible plasma levels -- In vitro bioequivalence testing -- In vitro dissolution profiles comparison -- Meta-analysis for bioequivalence review -- Population pharmacokinetics -- Other pharmacokinetic studies -- Review of regulatory guidances on bioequivalence -- Frequently asked questions and future challenges
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