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.‎ Drug Safety Data‎:‎ How to Analyze‎,‎ Summarize and Interpret to Determine Risk provides 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.‎ 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.‎ 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 reports * Pragmatic tips‎.‎‎.‎‎.‎and mistakes to avoid * Simple explanations of what safety data are collected‎,‎ and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug‎,‎ biologic or nutraceutical * Examples of user‎-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time‎,‎ resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL 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)‎