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Design and analysis of bioavailability and bioequivalence studies

Author: Shein-Chung Chow; Jen-pei Liu
Publisher: Boca Raton : CRC Press, ©2009.
Series: Chapman & Hall/CRC biostatistics series, 27.
Edition/Format:   eBook : Document : English : 3rd edView all editions and formats
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  Read more...

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Genre/Form: Electronic books
Additional Physical Format: Print version:
Chow, Shein-Chung, 1955-
Design and analysis of bioavailability and bioequivalence studies.
Boca Raton : CRC Press, ©2009
(DLC) 2008025461
(OCoLC)166358489
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Shein-Chung Chow; Jen-pei Liu
ISBN: 9781420011678 1420011677
OCLC Number: 288945451
Description: 1 online resource (xxii, 733 pages) : illustrations.
Contents: Design of bioavailability studies --
Statistical inferences for effects from a standard 2x2 crossover design --
Statistical methods for average bioequivalence --
Power and sample size determination --
Transformation and analysis of individual subject ratios --
Assessment of inter- and intra-subject 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.
Series Title: Chapman & Hall/CRC biostatistics series, 27.
Responsibility: Shein-Chung Chow, Jen-pei Liu.

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