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Multiple Testing Problems In Pharmaceutical Statistics

Author: Alex Dmitrienko
Publisher: CRC Press
ISBN: 9781584889854
Size: 57.74 MB
Format: PDF, ePub
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Useful Statistical Approaches for Addressing Multiplicity Issues Includes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple comparison research with an emphasis on pharmaceutical applications. In each chapter, the expert contributors describe important multiplicity problems encountered in pre-clinical and clinical trial settings. The book begins with a broad introduction from a regulatory perspective to different types of multiplicity problems that commonly arise in confirmatory controlled clinical trials, before giving an overview of the concepts, principles, and procedures of multiple testing. It then presents statistical methods for analyzing clinical dose response studies that compare several dose levels with a control as well as statistical methods for analyzing multiple endpoints in clinical trials. After covering gatekeeping procedures for testing hierarchically ordered hypotheses, the book discusses statistical approaches for the design and analysis of adaptive designs and related confirmatory hypothesis testing problems. The final chapter focuses on the design of pharmacogenomic studies based on established statistical principles. It also describes the analysis of data collected in these studies, taking into account the numerous multiplicity issues that occur. This volume explains how to solve critical issues in multiple testing encountered in pre-clinical and clinical trial applications. It presents the necessary statistical methodology, along with examples and software code to show how to use the methods in practice.

Cancer Clinical Trials

Author: Stephen L. George
Publisher: CRC Press
ISBN: 1315354330
Size: 25.94 MB
Format: PDF
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Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.

Modern Issues And Methods In Biostatistics

Author: Mark Chang
Publisher: Springer Science & Business Media
ISBN: 9781441998422
Size: 30.70 MB
Format: PDF
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Classic biostatistics, a branch of statistical science, has as its main focus the applications of statistics in public health, the life sciences, and the pharmaceutical industry. Modern biostatistics, beyond just a simple application of statistics, is a confluence of statistics and knowledge of multiple intertwined fields. The application demands, the advancements in computer technology, and the rapid growth of life science data (e.g., genomics data) have promoted the formation of modern biostatistics. There are at least three characteristics of modern biostatistics: (1) in-depth engagement in the application fields that require penetration of knowledge across several fields, (2) high-level complexity of data because they are longitudinal, incomplete, or latent because they are heterogeneous due to a mixture of data or experiment types, because of high-dimensionality, which may make meaningful reduction impossible, or because of extremely small or large size; and (3) dynamics, the speed of development in methodology and analyses, has to match the fast growth of data with a constantly changing face. This book is written for researchers, biostatisticians/statisticians, and scientists who are interested in quantitative analyses. The goal is to introduce modern methods in biostatistics and help researchers and students quickly grasp key concepts and methods. Many methods can solve the same problem and many problems can be solved by the same method, which becomes apparent when those topics are discussed in this single volume.

Multiple Comparisons Using R

Author: Frank Bretz
Publisher: CRC Press
ISBN: 9781420010909
Size: 40.96 MB
Format: PDF
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Adopting a unifying theme based on maximum statistics, Multiple Comparisons Using R describes the common underlying theory of multiple comparison procedures through numerous examples. It also presents a detailed description of available software implementations in R. The R packages and source code for the analyses are available at http://CRAN.R-project.org After giving examples of multiplicity problems, the book covers general concepts and basic multiple comparisons procedures, including the Bonferroni method and Simes’ test. It then shows how to perform parametric multiple comparisons in standard linear models and general parametric models. It also introduces the multcomp package in R, which offers a convenient interface to perform multiple comparisons in a general context. Following this theoretical framework, the book explores applications involving the Dunnett test, Tukey’s all pairwise comparisons, and general multiple contrast tests for standard regression models, mixed-effects models, and parametric survival models. The last chapter reviews other multiple comparison procedures, such as resampling-based procedures, methods for group sequential or adaptive designs, and the combination of multiple comparison procedures with modeling techniques. Controlling multiplicity in experiments ensures better decision making and safeguards against false claims. A self-contained introduction to multiple comparison procedures, this book offers strategies for constructing the procedures and illustrates the framework for multiple hypotheses testing in general parametric models. It is suitable for readers with R experience but limited knowledge of multiple comparison procedures and vice versa. See Dr. Bretz discuss the book.

Pharmaceutical Statistics Using Sas

Author: Alex Dmitrienko
Publisher: SAS Institute
ISBN: 1599943573
Size: 24.79 MB
Format: PDF
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Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.

The Analysis Of Covariance And Alternatives

Author: Bradley Huitema
Publisher: John Wiley & Sons
ISBN: 9781118067468
Size: 70.46 MB
Format: PDF, ePub, Mobi
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A complete guide to cutting-edge techniques and best practices for applying covariance analysis methods The Second Edition of Analysis of Covariance and Alternatives sheds new light on its topic, offering in-depth discussions of underlying assumptions, comprehensive interpretations of results, and comparisons of distinct approaches. The book has been extensively revised and updated to feature an in-depth review of prerequisites and the latest developments in the field. The author begins with a discussion of essential topics relating to experimental design and analysis, including analysis of variance, multiple regression, effect size measures and newly developed methods of communicating statistical results. Subsequent chapters feature newly added methods for the analysis of experiments with ordered treatments, including two parametric and nonparametric monotone analyses as well as approaches based on the robust general linear model and reversed ordinal logistic regression. Four groundbreaking chapters on single-case designs introduce powerful new analyses for simple and complex single-case experiments. This Second Edition also features coverage of advanced methods including: Simple and multiple analysis of covariance using both the Fisher approach and the general linear model approach Methods to manage assumption departures, including heterogeneous slopes, nonlinear functions, dichotomous dependent variables, and covariates affected by treatments Power analysis and the application of covariance analysis to randomized-block designs, two-factor designs, pre- and post-test designs, and multiple dependent variable designs Measurement error correction and propensity score methods developed for quasi-experiments, observational studies, and uncontrolled clinical trials Thoroughly updated to reflect the growing nature of the field, Analysis of Covariance and Alternatives is a suitable book for behavioral and medical scineces courses on design of experiments and regression and the upper-undergraduate and graduate levels. It also serves as an authoritative reference work for researchers and academics in the fields of medicine, clinical trials, epidemiology, public health, sociology, and engineering.

Pharmaceutical Statistics

Author: Sanford Bolton
Publisher: CRC Press
ISBN: 1420074237
Size: 74.18 MB
Format: PDF, ePub, Mobi
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Through the use of practical examples and solutions, Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition provides the most complete and comprehensive guide to the various statistical applications and research issues in the pharmaceutical industry, particularly in clinical trials and bioequivalence studies.

Statistical Thinking For Non Statisticians In Drug Regulation

Author: Richard Kay
Publisher: John Wiley & Sons
ISBN: 1118470974
Size: 70.50 MB
Format: PDF, Docs
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Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials. It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials. Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis. Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry.

Statistik F R Dummies

Author: Deborah J. Rumsey
Publisher: John Wiley & Sons
ISBN: 3527692762
Size: 25.55 MB
Format: PDF, ePub, Mobi
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Von A wie Ausreißer bis Z wie Z-Verteilung Entdecken Sie mit Statistik für Dummies Ihren Spaß an der Statistik und werfen Sie einen Blick hinter die Kulissen dieser komplizierten, aber hilfreichen Wissenschaft! Deborah Rumsey zeigt Ihnen das nötige statistische Handwerkszeug wie Stichprobe, Wahrscheinlichkeit, Bias, Median, Durchschnitt und Korrelation. Sie lernen die verschiedenen grafischen Darstellungsmöglichkeiten von statistischem Material kennen und werden über die unterschiedlichen Methoden der Auswertung erstaunt sein. Schärfen Sie mit diesem Buch Ihr Bewusstsein für Zahlen und deren Interpretation, sodass Ihnen keiner mehr etwas vormachen kann!