Design and analysis of bioavailability and bioequivalence studies / Shein-Chun Chow, Jen-pei Liu
Material type:
TextSeries: Chapman & Hall/CRC biostatistics series ; 27Publication details: Boca Raton, Florida : CRC Press, c2009Edition: 3rd edDescription: xxii, 733 p. : ill. ; 25 cmISBN: - 9781584886686
| Item type | Current library | Call number | Copy number | Status | Date due | Barcode | |
|---|---|---|---|---|---|---|---|
Open Shelf
|
UMPLIB GAMBANG | RM301.6 .C46 2009 (Browse shelf(Opens below)) | 1 | Available | 0000052382 |
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.