Design and analysis of bioavailability and bioequivalence studies
By: authors, Shein-Chun Chow, Jen-pei Liu.
Contributors: Liu, Jen-pei, 1952-
Edition: 3rd ed.
Series: Chapman & Hall/CRC biostatistics series -- 27
Publisher: Chapman & Hall/CRC
Published: 2009
Place of publication: Boca Raton
Language: eng
ISBN-13: 9781584886686
Subjects: Bioavailability -- Research -- Statistical methods; Drugs -- Therapeutic equivalency -- Research -- Statistical methods; Biological Availability; Statistics as Topic -- methods; Therapeutic Equivalency
Notes: Includes bibliographical references and index.
Table of contents: title: Design of bioavailability studies; title: Statistical inferences for effects from a standard 22 crossover design; title: Statistical methods for average bioequivalence; title: Power and sample size determination; title: Transformation and analysis of individual subject ratios; title: Assessment of inter- and intrasubject variabilities; title: Assumptions of outlier detection for average bioequivalence; title: Optimal crossover designs for two formulations for average bioequivalence; title: Assessment of bioequivalence for more than two formulations; title: Population and individual bioequivalence; title: Statistical procedures for assessment of population and individual bioequivalence; title: Assessment of bioequivalence for drugs with negligible plasma levels; title: In vitro bioequivalence testing; title: In vitro dissolution profiles comparison; title: Meta-analysis for bioequivalence review; title: Population pharmacokinetics; title: Other pharmacokinetic studies; title: Review of regulatory guidances on bioequivalence; title: Frequently asked questions and future challenges.