Main description:

Preeminent Experts Update a Well-Respected Book

Taking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides 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 literature

Like its bestselling predecessors, this edition covers all of the statistical problems 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.

Contents:

Preface. Preliminaries. Average Bioequivalence. Population and Individual Bioequivalence. In Vitro and Alternative Evaluation of Bioequivalence. Other Bioequivalence Studies. References. Appendices. Index.