Design and analysis of bioavailability and bioequivalence studies
| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York :
Marcel Dekker ,
c2000
|
| Edition: | 2nd ed. revised and expanded |
| Subjects: |
Table of Contents:
- 1. Introduction
- 2. Designs of bioavailability studies
- 3. Statistical inferences for effects from a standard 2x2 crossover design
- 4. Statistical methods for average bioavailability
- 5. Power and sample size determination
- 6. Transformation and analysis of individual subjects rations
- 7. The assessment of inter and intrasubject variabilities
- 8. Assumptions and outliers detection
- 9. Optimal crossover designs for two formulations
- 10. Assessment of bioequivalence for more than two formulations
- 11. Assessment of bioequivalence for drugs with negligible plasma levels
- 12. Some related problems in bioavailability studies
- 13. Meta-Analysis for bioequivalence review
- 14. Population and individual bioequivalence
- 15. Statistical procedures for assessment of population and individual bioequivalence
- 16. Review of FDA guidances