Chow, Shein-Chung creator Liu, Jen-pei text flu Boca Raton, Florida CRC Press c2009 2009 3rd ed. monographic eng

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xxii, 733 p. : ill. ; 25 cm. 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. specialized Shein-Chun Chow, Jen-pei Liu Includes bibliographical references (p. 647-667) and index Bioavailability Research Statistical methods Drugs Therapeutic equivalency Research Statistical methods 9781584886686 http://www.loc.gov/catdir/toc/ecip0821/2008025461.html http://www.loc.gov/catdir/toc/ecip0821/2008025461.html UMP 100705 20251117142456.0 vtls000046973