Design and analysis of bioavailability and bioequivalence studies
Author(s)
Bibliographic Information
Design and analysis of bioavailability and bioequivalence studies
（Statistics : textbooks and monographs, v. 133）
M. Dekker, c1992
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Note
Includes bibliographical references and index
Description and Table of Contents
Description
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.
Table of Contents
- 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.
by "Nielsen BookData"
