TY  - BOOK
AU  - Chow,Shein-Chung
AU  - Liu,Jen-pei
TI  - Design and analysis of bioavailability and bioequivalence studies
T2  - Chapman & Hall/CRC biostatistics series
SN  - 9781584886686
U1  - 615.7 23
PY  - 2009///
CY  - Boca Raton
PB  - CRC Press
KW  - Bioavailability
KW  - Research
KW  - Statistical methods
KW  - Drugs
KW  - Therapeutic equivalency
KW  - Biological Availability
N1  - Includes bibliographical references and index; 1. Introduction --
2. Design of bioavailability studies --
3. Statistical inferences for effects from a standard 2x2 crossover design --
4. Statistical methods for average bioequivalence --
5. Power and sample size determination --
6. Transformation and analysis of individual subject ratios --
7. Assessment of inter- and intra-subject variabilities --
8. Assumptions of outlier detection for average bioequivalence --
9. Optimal crossover designs for two formulations for average bioequivalence --
10. Assessment of bioequivalence for more than two formulations --
11. Population and individual bioequivalence --
12. Statistical procedures for assessment of population and individual bioequivalence --
13. Assessment of bioequivalence for drugs with negligible plasma levels --
14. In vitro bioequivalence testing --
15. In vitro dissolution profiles comparison --
16. Meta-analysis for bioequivalence review --
17. Population pharmacokinetics --
18. Other pharmacokinetic studies --
19. Review of regulatory guidances on bioequivalence --
20. Frequently asked questions and future challenges --
Appendices
N2  - Offers a presentation of various activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology. This book covers statistical problems that may occur in the various stages of design and data analysis
ER  -