Design and Analysis of Bioavailability and Bioequivalence Studies - Couverture rigide

Chow, Shein-Chung; Liu, Jen-pei

Couverture rigide

ISBN 10 : 0824786823 ISBN 13 : 9780824786823

Editeur : Marcel Dekker Inc, 1992

Synopsis

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.

A propos du livre

Présentation de l'éditeur

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.

Présentation de l'éditeur

"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."

Détails de l'édition

• Éditeur: Marcel Dekker Inc
• Date d'édition: 1992
• Langue: anglais
• ISBN 10: 0824786823
• ISBN 13: 9780824786823
• Reliure: Relié
• Nombre de pages: 432
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible