Design and analysis of bioavailability and bioequivalence studies / Shein-Chun Chow, Jen-pei Liu.
| Author/creator | Chow, Shein-Chung, 1955- |
| Other author | Liu, Jen-pei, 1952- |
| Format | Electronic |
| Edition | 3rd ed. |
| Publication Info | Boca Raton : CRC Press, |
| Description | xxii, 733 p. : ill. ; 25 cm. |
| Supplemental Content | Full text available from eBooks on EBSCOhost |
| Subjects |
| Series | Chapman & Hall/CRC biostatistics series ; 27 |
| Contents | 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. |
| General note | "A Chapman & Hall book." |
| Bibliography note | Includes bibliographical references (p. 647-667) and index. |
| Access restriction | Available only to authorized users. |
| Technical details | Mode of access: World Wide Web |
| Genre/form | Electronic books. |
| LCCN | 2008025461 |
| ISBN | 9781584886686 (hardback : alk. paper) |
| ISBN | 1584886684 (hardback : alk. paper) |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |