Bioequivalence studies in drug development [electronic resource] : methods and applications / Dieter Hauschke, Volker Steinijans, Iris Pigeot.
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| Online Access: |
Full Text (via Wiley) |
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| Main Author: | |
| Other Authors: | , |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Chichester, England ; Hoboken, NJ :
Wiley,
©2007.
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| Series: | Statistics in practice.
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| Subjects: |
Table of Contents:
- Metrics to characterize concentration-time profiles in single- and multiple-dose bioequivalence studies
- Basic statistical considerations
- Assessment of average bioequivalence in the RT/TR design
- Power and sample size determination for testing average bioequivalence in the RT/TR design
- Presentation of bioequivalence studies
- Designs with more than two formulations
- Analysis of pharmacokinetic interactions
- Population and individual bioequivalence
- Equivalence assessment for clinical endpoints.