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

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Jones & Bartlett Learning, Oct 25, 2010 - Medical - 312 pages
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)
 

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Contents

The Basics
1
Approaches to the Analysis Summary and Interpretation of Safety Data
89
Appendix I
191
Appendix II
197
Appendix III
271
Appendix IV
279
Appendix V
291
Index
297
Copyright

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About the author (2010)

Dr. Michael J. Klepper is an independent consultant who specializes in pharmacovigilance and drug safety.He graduated from Loyola University Stritch School of Medicine, was elected to Alpha Omega Alpha (National Medical Honor Society) and received board certification in Internal Medicine and Emergency Medicine. As President and CEO of Integrated Safety Systems, Inc. (ISS) and as Vice President of Safety and Pharmacovigilance at Research Triangle Institute - Health Solutions (RTI-HS), Dr. Klepper provided comprehensive pharmacovigilance-related services to numerous pharmaceutical and biotech clients.His 25 years of industry experience also includes preparation of the Integrated Summary of Safety, Summary of Clinical Safety, Periodic Safety Update Reports, and other safety reports; medical product safety training; and global drug development. Of particular importance to Dr. Klepper is comprehensive medical review and ongoing benefit-risk determination for pre- and postmarketed medical products.He also has a keen interest in the evaluation and application of new technological tools and their uses for enhancing risk assessment.Dr. Klepper frequently lectures as a drug safety expert and is president of Michael J. Klepper, MD, LLC based in Research Triangle Park, North Carolina.

President, BLCMD Associates LLC, Westfield, New Jersey

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