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Design and analysis of bioavailability and bioequivalence studies / Shein-Chun Chow and Jen-pei Liu.

By: Contributor(s): Material type: TextTextSeries: Chapman & Hall/CRC biostatistics series ; 27.Publication details: Boca Raton : CRC Press, ©2009.Edition: 3rd edDescription: xxii, 733 pages : illustrations ; 25 cmISBN:
  • 9781584886686
Subject(s): DDC classification:
  • 615.7 23 C552
Contents:
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.
Summary: 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.
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Holdings
Item type Current library Call number Status Date due Barcode Item holds
Books ISI Library, Kolkata 615.7 C552 (Browse shelf(Opens below)) Available 138124
Total holds: 0

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.

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.

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