Design and analysis of bioavailability and bioequivalence studies [electronic resource] / authors, Shein-Chun Chow, Jen-pei Liu.
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| Online Access: |
Full Text (via Taylor & Francis) |
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| Main Author: | |
| Other Authors: | |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Boca Raton :
Chapman & Hall/CRC,
2009.
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| Edition: | 3rd ed. |
| Series: | Chapman & Hall/CRC biostatistics series ;
27. |
| Subjects: |
Table of Contents:
- Design of bioavailability studies
- Statistical inferences for effects from a standard 22 crossover design
- Statistical methods for average bioequivalence
- Power and sample size determination
- Transformation and analysis of individual subject ratios
- Assessment of inter- and intrasubject 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.