Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment, providing drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data.With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting.Key Features Include: Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reportsPragmatic tips...and mistakes to avoidSimple explanations of what safety data are collected, and what the data meanPractical approaches to determining a drug effect and understanding its clinical significanceGuidance for determining risk throughout the lifecycle of a drug, biologic or nutraceuticalExamples of user-friendly data displays that enhance safety signal identificationWays to improve data quality and reduce the time, resources and costs involved in mandatory safety reportingRelevant material for the required training of drug safety/pharmacovigilance professionalsSPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR) (c) 2011 316 pages