Multiple Testing Problems in Pharmaceutical Statistics

ISBN-13: 9781584889847 / Angielski / Twarda / 2009 / 304 str.

Ph.D. Alex Dmitrienko; Ajit C. Tamhane; Frank Bretz

Opis

This book explains how to solve the most important problems in multiple testing encountered in drug discovery, pre-clinical, and clinical trial applications. It presents relevant statistical methodology; illustrates the methodology using real-life examples from drug discovery experiments, pre-clinical studies, and clinical trials; and provides software code (SAS, S-Plus, R) for solving the problems. It describes statistical strategies for handling multiplicity issues in the pharmaceutical industry and covers basic/traditional multiple testing procedures as well as novel approaches to performing multiple inferences. The book also discusses regulatory issues.

Spis treści

Multiplicity Problems in Clinical Trials: A Regulatory Perspective. Multiple Testing Methodology. Multiple Testing in Dose Response Problems. Analysis of Multiple Endpoints in Clinical Trials. Gatekeeping Procedures in Clinical Trials. Adaptive Designs and Confirmatory Hypothesis Testing. Design and Analysis of Microarray Experiments for Pharmacogenomics. Bibliography.