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Robert D. Gibbons,Anup Amatya

Statistical Methods for Drug Safety

Statistical Methods for Drug Safety

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  • More about Statistical Methods for Drug Safety

Statistical Methods for Drug Safety is a comprehensive guide to statistical approaches for analyzing pharmacoepidemiologic data, covering commonly used techniques, newer approaches, and causal inference models. It is authored by two professors at the forefront of developing new statistical methodologies and encourages statistical scientists to develop new methods.

Format: Paperback / softback
Length: 308 pages
Publication date: 21 January 2023
Publisher: Taylor & Francis Ltd


Statistical Methods for Drug Safety presents a comprehensive range of statistical approaches for analyzing pharmacoepidemiologic data. It encompasses both commonly employed techniques, such as proportional reporting ratios for the analysis of spontaneous adverse event reports, and newer methods, such as the utilization of marginal structural models to control dynamic selection bias in the analysis of large-scale longitudinal observational data.

Selecting the Appropriate Statistical Approach for Analyzing Your Drug Safety Data

The book delves into linear and non-linear mixed-effects models, discrete-time survival models, and novel methodologies for conducting meta-analyses 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 valuable 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.

Advancing Statistical Practice in Pharmacoepidemiology
Authored by two esteemed professors at the forefront of developing innovative statistical methodologies to address pharmacoepidemiologic problems, this book serves as a cohesive compendium of statistical methods readily accessible to pharmacoepidemiologists. Furthermore, it encourages statistical scientists to explore new approaches that extend beyond the current state of the art.

Weight: 570g
Dimension: 234 x 156 (mm)
ISBN-13: 9781032477299

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