Design and Analysis of Bioavailability and

Taking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Editionprovides a complete presentation of the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology.New to the Third Edition'¢ Four new chapters that present a thorough account of novel developments in the field'¢ New and updated sections that reflect recent advances in the statistical methodology in the design and analysis of bioavailability and bioequivalence studies'¢ Reorganization of the material into five parts, making it easier to access related information together'¢ Over 100 new references from the literatureLike its bestselling predecessors, this edition covers all of the statisticalproblems that may occur in the various stages of design and data analysis. Keeping the mathematics and statistics at a fundamental level, it continues to focus on practical concepts rather than technical details.

Preliminaries
Introduction
Design of Bioavailability Studies
Statistical Inference for Effects from a Standard 2 x 2 Crossover Design
Average Bioequivalence
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
Population and Individual Bioequivalence
Statistical Procedures for Assessment of Population and Individual Bioequivalence
In Vitro and Alternative Evaluation of Bioequivalence
Assessment of Bioequivalence for Drugs with Negligible Plasma Levels
In Vitro Bioequivalence Testing
In Vitro Dissolution Profiles Comparison
Other Bioequivalence Studies
Meta-Analysis for Bioequivalence Review
Population Pharmacokinetics
Other Pharmacokinetic Studies
Review of Regulatory Guidances on Bioequivalence
Frequently Asked Questions and Future Challenges
References
Statistical Tables
SAS Programs
Index
Table of Contents provided by Blackwell. All Rights Reserved.

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Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition

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