Design and analysis of bioavailability and bioequivalence studies

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書誌事項

Design and analysis of bioavailability and bioequivalence studies

Shein-Chung Chow, Jen-pei Liu

（Statistics : textbooks and monographs, v. 133）

M. Dekker, c1992

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注記

Includes bibliographical references and index

内容説明・目次

内容説明

This practical reference/text, written at a basic mathematical and statistical level, presents important statistical concepts for assessing bioequivalence through "real" examples and provides a thorough, unified discussion of the design and analysis of bioavailability and bioequivalence studies. Furnishing a comprehensive overview of the field and comparing average bioavailability methods, "Design and Analysis of Bioavailability and Bioequivalence Studies": supplies a simple formula for sample size determination; explains techniques for checking model assumptions and detecting outlying data; compares the additive model and the multiplicative model; demonstrates statistical methods of assessing more than two formulations; and delineates bioequivalence assessment with negligible plasma levels. As a fundamental text in the classroom or for self-education, "Design and Analysis of Bioavailability and Bioequivalence Studies": contains various study designs based on different needs and objectives; offers over 400 display equations but requires no mathematics beyond simple algebra; and incorporates time-saving SAS programmes and an appendix of statistical tables. "Design and Analysis of Bioavailability and Bioequivalence Studies" is intended for biostatisticians; applied statisticians; biometricians; pharmacologists; clinical, industrial and research pharmacists; and drug regulatory personnel; as well as an for all upper-level undergraduate and graduate courses in bioavailability and bioequivalence, pharmacokinetics, pharmaceutics and biostatistics.

目次

  • Designs of bioavailability studies
  • statistical inferences for effects from a standard 2x2 crossover design
  • statistical methods for average bioavailability
  • power and sample size determination
  • transformation and analysis of individual subject ratios
  • the assessment of inter- and intra-subject variabilities
  • assumptions and outliers detection
  • optimal crossover designs for two formulations
  • assessment of bioequivalence for more than two formulations
  • assessment of bioequivalence for drugs with negligible plasma levels
  • some related problems in bioavailability studies
  • references
  • appendix a - statistical tables
  • appendix b - SAS programmes.

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