Design and Analysis of Bioavailability and Bioequivalence Studies, Second Edition

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CRC Press, Nov 24, 1999 - Mathematics - 600 pages
2 Reviews
"Provides a comprehensive summary of the continuously growing literature and research activities on the regulatory requirements, scientific and practical issues, and statistical methodology of the design and analysis of bioavailability and bioequivalence studies. Includes several new chapters."
 

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Contents

Introduction
1
Designs of Bioavailability Studies
31
Statistical Inferences for Effects from a Standard 2x2 Crossover Design
57
Statistical Methods for Average Bioavailability
79
Power and Sample Size Determination
125
Transformation and Analysis of Individual Subject Ratios
161
The Assessment of Inter and Intrasubject Variabilities
187
Assumptions and Outliers Detection
221
Assessment of Bioequivalence for Drugs with Negligible Plasma Levels
333
Some Related Problems in Bioavailability Studies
361
MetaAnalysis for Bioequivalence Review
379
Population and Individual Bioequivalence
401
Statistical Procedures for Assessment of Population and Individual Bioequivalence
443
Review of FDA Guidances
489
References
521
Statistical Tables
537

Optimal Crossover Designs for Two Formulations
257
Assessment of Bioequivalence for More Than Two Formulations
303
SAS Programs
557
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