Statistical Methods For Drug Safety
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Statistical Methods for Drug Safety
Explore Important Tools for High-Quality Work in Pharmaceutical Safety Statistical Methods for Drug Safety presents a wide variety of statistical approaches for analyzing pharmacoepidemiologic data. It covers both commonly used techniques, such as proportional reporting ratios for the analysis of spontaneous adverse event reports, and newer approaches, such as the use of marginal structural models for controlling dynamic selection bias in the analysis of large-scale longitudinal observational data. Choose the Right Statistical Approach for Analyzing Your Drug Safety Data The book describes linear and non-linear mixed-effects models, discrete-time survival models, and new approaches to the meta-analysis of rare binary adverse events. It explores research involving the re-analysis of complete longitudinal patient records from randomized clinical trials. The book discusses causal inference models, including propensity score matching, marginal structural models, and differential effects, as well as mixed-effects Poisson regression models for analyzing ecological data, such as county-level adverse event rates. The authors also cover numerous other methods useful for the analysis of within-subject and between-subject variation in adverse events abstracted from large-scale medical claims databases, electronic health records, and additional observational data streams. Advance Statistical Practice in Pharmacoepidemiology Authored by two professors at the forefront of developing new statistical methodologies to address pharmacoepidemiologic problems, this book provides a cohesive compendium of statistical methods that pharmacoepidemiologists can readily use in their work. It also encourages statistical scientists to develop new methods that go beyond the foundation covered in the text.
Quantitative Evaluation of Safety in Drug Development
State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product deve
Statistical Methods for Evaluating Safety in Medical Product Development
Author: A. Lawrence Gould
language: en
Publisher: John Wiley & Sons
Release Date: 2015-02-23
This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code