"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability (Statistics: Textbooks and Monographs)

Science & Math

Chow, Shein-Chung

Liu, Jen-Pei

Mathematics

CRC-Press

Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” ―Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include: • New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine • A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts • New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines • An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.

Design and Analysis of Clinical Trials: Concepts and Methodologies

Biological Sciences

wiley

A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, the principles presented here are universal enough to be easily adapted in non-biopharmaceutical settings. Design and Analysis of Clinical Trials tackles concepts and methodologies. It not only covers statistical basics such as uncertainty and bias, design considerations such as patient selection, randomization, and the different types of clinical trials but also deals with various methods of data analysis, group sequential procedures for interim analysis, efficacy data evaluation, analysis of safety data, and more. Throughout, the book: * Surveys current and emerging clinical issues and newly developed statistical methods * Presents a critical review of statistical methodologies in various therapeutic areas * Features case studies from actual clinical trials * Minimizes the mathematics involved, making the material widely accessible * Offers each chapter as a self-contained entity * Includes illustrations to highlight the text This monumental reference on all facets of clinical trials is important reading for physicians, clinical and medical researchers, pharmaceutical scientists, clinical programmers, biostatisticians, and anyone involved in this burgeoning area of clinical research. It can also be used as a textbook in graduate-level courses in the field.

Design and Analysis of Clinical Trials: Concept and Methodologies (Wiley Series in Probability and Statistics)

Wiley-Interscience

Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." –Statistical Methods in Medicine A complete and balanced presentation now revised, updated, and expanded As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH). Design and Analysis of Clinical Trials, Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as: <ul>
<li>Clinical trials and regulations, especially those of the ICH</li> <li>Clinical significance, reproducibility, and generalizability</li> <li>Goals of clinical trials and target population</li> <li>New study designs and trial types</li> <li>Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities</li> </ul>
Also, three entirely new chapters cover: <ul>
<li>Designs for cancer clinical trials</li> <li>Preparation and implementation of a clinical protocol</li> <li>Data management of a clinical trial</li> </ul>
Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.

"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."

Design and Analysis of Bioavailability and Bioequivalence Studies, Second Edition (Chapman & Hall/CRC Biostatistics Series)

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.

Design and Analysis of Bioavailability and Bioequivalence Studies (STATISTICS, A SERIES OF TEXTBOOKS AND MONOGRAPHS)

Marcel Dekker, Inc.

Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability (STATISTICS, A SERIES OF TEXTBOOKS AND MONOGRAPHS)

Design and Analysis of Bioavailability and Bioequivalence Studies (Chapman & Hall/CRC Biostatistics Series)

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 <ul>
<li>Four new chapters that present a thorough account of novel developments in the field</li> <li>New and updated sections that reflect recent advances in the statistical methodology in the design and analysis of bioavailability and bioequivalence studies</li> <li>Reorganization of the material into five parts, making it easier to access related information together</li> <li>Over 100 new references from the literature</li> </ul> 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.

Chapman and Hall/CRC

See the best price to sell, buy, or rent books by Liu, Jen-Pei. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Books by Liu, Jen-Pei

See the best price to sell, buy, or rent books by Liu, Jen-Pei. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability (Statistics: Textbooks and Monographs)

Design and Analysis of Clinical Trials: Concepts and Methodologies

Design and Analysis of Clinical Trials: Concept and Methodologies (Wiley Series in Probability and Statistics)

Design and Analysis of Clinical Trials: Concepts and Methodologies

Design and Analysis of Bioavailability and Bioequivalence Studies, Second Edition (Chapman & Hall/CRC Biostatistics Series)

Design and Analysis of Bioavailability and Bioequivalence Studies (STATISTICS, A SERIES OF TEXTBOOKS AND MONOGRAPHS)

Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability (STATISTICS, A SERIES OF TEXTBOOKS AND MONOGRAPHS)

Design and Analysis of Bioavailability and Bioequivalence Studies (Chapman & Hall/CRC Biostatistics Series)

Design and Analysis of Bioavailability and Bioequivalence Studies (Chapman & Hall/CRC Biostatistics Series)