Clinical trials, Brody, Tom (consultant For Second Genome, Inc. (crohn`s Disease), Rigel Pharmaceuticals (platelet Disorder), Primegen Biotech (stem Cell Therapy), Reg
Название: Design and Analysis of Clinical Trials with Time-to-Event Endpoints ISBN: 1420066390 ISBN-13(EAN): 9781420066395 Издательство: Taylor&Francis Рейтинг: Цена: 148010.00 T Наличие на складе: Есть у поставщика Поставка под заказ. 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.
Автор: Fairclough Название: Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edition ISBN: 1420061178 ISBN-13(EAN): 9781420061178 Издательство: Taylor&Francis Рейтинг: Цена: 148010.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Presents a range of solutions to analytic issues. This title reflects developments in methodology with coverage of mixture models and a dataset example. It implements examples using SAS and R code and incorporates a number of examples from real QoL clinical trials to illustrate design and analysis methods.
Автор: Wassmer Название: Group Sequential and Confirmatory Adaptive Designs in Clinical Trials ISBN: 3319325604 ISBN-13(EAN): 9783319325606 Издательство: Springer Рейтинг: Цена: 121110.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population. Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods and methods for the determination of an overall p-value. Part I of the book provides the group sequential methods that are necessary for understanding and applying the adaptive design methodology supplied in Parts II and III of the book. The book contains many examples that illustrate use of the methods for practical application. The book is primarily written for applied statisticians from academia and industry who are interested in confirmatory adaptive designs. It is assumed that readers are familiar with the basic principles of descriptive statistics, parameter estimation and statistical testing. This book will also be suitable for an advanced statistical course for applied statisticians or clinicians with a sound statistical background.
Автор: Chow, Shein-chung Название: Controversial statistical issues in clinical trials ISBN: 0367576937 ISBN-13(EAN): 9780367576936 Издательство: Taylor&Francis Рейтинг: Цена: 48990.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Written by one of the preeminent experts in the field, this book covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. It focuses on issues occurring at various stages of clinical research and development, including early-phase clinical development
Автор: Berry, Donald A. Berry, Scott M. Carlin, Bradley P Название: Bayesian adaptive methods for clinical trials ISBN: 1439825483 ISBN-13(EAN): 9781439825488 Издательство: Taylor&Francis Рейтинг: Цена: 112290.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. This book summarizes the state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative.
Автор: Atkinson, Anthony C , Biswas, Atanu Название: Randomised Response-Adaptive Designs in Clinical Trials ISBN: 0367378973 ISBN-13(EAN): 9780367378974 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
Randomised Response-Adaptive Designs in Clinical Trials presents methods for the randomised allocation of treatments to patients in sequential clinical trials. Emphasizing the practical application of clinical trial designs, the book is designed for medical and applied statisticians, clinicians, and statisticians in training.
After introducing clinical trials in drug development, the authors assess a simple adaptive design for binary responses without covariates. They discuss randomisation and covariate balance in normally distributed responses and cover many important response-adaptive designs for binary responses. The book then develops response-adaptive designs for continuous and longitudinal responses, optimum designs with covariates, and response-adaptive designs with covariates. It also covers response-adaptive designs that are derived by optimising an objective function subject to constraints on the variance of estimated parametric functions. The concluding chapter explores future directions in the development of adaptive designs.
Автор: Li Gang, Binkowitz Bruce, Wang William Название: Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17 ISBN: 0367565609 ISBN-13(EAN): 9780367565602 Издательство: Taylor&Francis Рейтинг: Цена: 163330.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book contains chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products.
Автор: Cook, Prof Jonathan A. (associate Professor, Associate Professor, Centre For Statistics In Medicine, Nuffield Department Of Orthopaedics, Rheumatology Название: Introduction to clinical trials ISBN: 0198885237 ISBN-13(EAN): 9780198885238 Издательство: Oxford Academ Рейтинг: Цена: 42230.00 T Наличие на складе: Есть у поставщика Поставка под заказ.
Название: Drug-Drug Interactions ISBN: 036745274X ISBN-13(EAN): 9780367452742 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical, toxicological, and regulatory perspectives.
Thoroughly updated, this second edition reflects the significant advances and includes extensive new material on:
key interplay between transporters and enzymes in drug metabolism and drug interactions
the integral role of pharmacogenetics in metabolism-based drug-drug interactions
in vivo - in vitro correlations (reversible, mechanism-based inhibition, induction)
in silico approaches enabling structure-activity and structure-function studies
high-throughput screening and GLP methods for evaluating drug interactions in vitro
the use of transgenic animal models to evaluate drug interactions
Providing helpful case examples and computer-aided modeling, Drug-Drug Interactions is filled with over 200 invaluable tables, equations, and figures to clarify key concepts, and incorporates critical new updated information.
Автор: Hayes Название: Cluster Randomised Trials, Second Edition ISBN: 1498728227 ISBN-13(EAN): 9781498728225 Издательство: Taylor&Francis Рейтинг: Цена: 132710.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Cluster Randomised Trials, Second Edition explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, it covers basic concepts underlying the use of cluster randomisation.
Автор: Chin, Richard Название: Global Clinical Trials ISBN: 0128103558 ISBN-13(EAN): 9780128103555 Издательство: Elsevier Science Рейтинг: Цена: 102180.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials.
Автор: Ton J. Cleophas; Aeilko H. Zwinderman; Toine F. Cl Название: Statistics Applied to Clinical Trials ISBN: 1402095228 ISBN-13(EAN): 9781402095221 Издательство: Springer Рейтинг: Цена: 69830.00 T Наличие на складе: Поставка под заказ. Описание: Explains classical statistical analysis of clinical trials. This book addresses relatively novel issues, including equivalence testing, interim analysis, sequential analysis, meta-analysis, and provides a framework of the best statistical methods available for such purpose. It is suitable for investigators in the field of clinical trials.
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