Описание: Using SAS, SPSS, and R, this book addresses design and analysis aspects in enough detail so that readers can apply statistical methods to their own longitudinal studies. This edition includes a new chapter on testing models that involve moderation and mediation, a new chapter on QALYs and QTWiST specific to clinical trials, and recent methodological developments for the analysis of trials with missing data. It also presents revised discussions of multiple comparisons procedures that focus on the integration of HRQoL outcomes with other study outcomes using gatekeeper strategies. Data sets, examples, applications, and SAS, R, and SPSS code are available on the book’s website.
Описание: These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. Geared toward graduate level students and scientists in the areas of clinical pharmacology and PK, the volumes will fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs, including first-time-in-man, biopharmaceuticals, and special population studies. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.
Описание: A practical guide to methods of survival analysis for medical researchers with limited statistical experience. Methods and techniques described range from descriptive and exploratory analysis to multivariate regression methods. Uses illustrative data from actual clinical trials and observational studies to describe methods of analysing and reporting results. Also reviews the features and performance of statistical software available for applying the methods of analysis discussed.
Автор: Fayers, Peter; Hays, Ron Название: Assessing Quality of Life in Clinical Trials ISBN: 0198527691 ISBN-13(EAN): 9780198527695 Издательство: Oxford Academ Рейтинг: Цена: 11449 р. Наличие на складе: Невозможна поставка.
Описание: Researchers in all clinical fields are fully aware of the importance of Quality of Life measurements in judging the efficacy of a given treatment. Psychological criteria play an important role in this evaluation. Assessing Quality of Life in Clinical Trials explores the current state of the art and illustrates the benefits and potential of health related quality of life assessment in clinical trials. It cover a wide range of analytical issues, emphasizing new and innovative approaches that are of practical and clinical importance. The book will have widespread appeal to clinical trialists and researchers from a wide range of specialties.
Описание: This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace-offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies.
The only wide-ranging, up-to-date book of its kind available on the subject!
Describing both the science and management of product development, Drug Products for Clinical Trials
furnishes effective approaches for preclinical drug discovery
addresses the function of the clinical trials materials manager
covers the design of clinical protocols in developing a new chemical entity (NCE)
explains the importance of bioequivalence between clinical trials materials and final products
demonstrates rapid, reliable processes for clinical evaluation
discusses the interaction between clinical research, manufacturing, and packaging
reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world
and much more!
Автор: Halloran, M. Elizabeth Longini, Ira M. Struchiner, Название: Design and analysis of vaccine studies ISBN: 0387403132 ISBN-13(EAN): 9780387403137 Издательство: Springer Рейтинг: Цена: 14959 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: As well as being a reference for the design, analysis, and interpretation of vaccine studies, the text covers all design and analysis stages, from vaccine development to post-licensure surveillance, presenting likelihood, frequentists, and Bayesian approaches.
Описание: Containing the historical and statistical information necessary to choose an analysis method and successful drug combination, Evaluating Synergy provides a systematic introduction of statistical methods for optimally designing and analyzing combination
Автор: Hsiao Название: Design and Analysis of Bridging Studies ISBN: 1439846340 ISBN-13(EAN): 9781439846346 Издательство: Taylor&Francis Рейтинг: Цена: 9090 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol. Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the necessity of bridging studies, types of bridging studies, and the assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, the text considers regional differences, assesses the consistency of treatment effect across regions, and discusses sample size determination for each region. Taking into account the International Conference Harmonisation (ICH) E5 framework for bridging studies, the book provides a unified summary of the growing literature and research activities in this area. It covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials, with the goal of inspiring new research activities in the field.
Описание: Provides a presentation of the design, monitoring, analysis, and interpretation of clinical trials in which time-to-event is of critical interest. This book discusses the design and monitoring of Phase II and III clinical trials with time-to-event endpoints.
Описание: 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 Editio
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