Design and analysis of bioavailability and bioequivalence studies

• 作者： Chow, Shein-Chung, 1955-
• 其他作者：
  • Liu, Jen-Pei, 1952-
• 出版： Boca Raton : CRC Press
• 版本：3rd ed.
• 叢書名： Chapman & Hall/CRC biostatistics series27
• 主題： Bioavailability--Research--Statistical methods. , Drugs--Therapeutic equivalency--Research--Statistical methods. , Biological Availability , Statistics as Topic--methods. , Therapeutic Equivalency
• ISBN： 1584886684 (hbk): US$85.96 、 9781584886686 (hbk.): US$85.96
• 資料類型: 圖書
• 內容註: Includes bibliographical references (p. 647-667) and index. 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. "A Chapman & Hall book."
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