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

Author(s): Michael J. Klepper, MD, President, Michael J. Klepper, MD, LLC, Research Triangle Park, North Carolina
Barton Cobert, MD, FACP, FACG, FFPM, President, BLCMD Associates LLC, Westfield, New Jersey
  • ISBN-13: 9780763769123
  • Paperback    316 pages      © 2011
Price: $157.95 US List
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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 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)
Part  1  The Basics
  Chapter  1  Benefit-Risk
  Chapter  2  Begin at the End
  Chapter  3  The “Dynamic” Integrated Safety Database - Something You Shouldn’t Live Without
  Chapter  4  Coding Basics
  Chapter  5  Determining Causality – The Individual Case Safety Report
  Chapter  6  Determining Causality – Aggregate Data
  Chapter  7  Determining the Weight of Evidence – Patterns and Links
  Chapter  8  Determining Clinical Significance…and Then What?
  Chapter  9  Clinical Laboratory Tests - What Is Measured; What It Means
  Chapter  10  12-Lead Electrocardiograms - What Is Measured; What It Means
  Chapter  11  Adverse Events That Should Be on Everyone's Radar Screen
Part  2  Approaches to the Analysis, Summary, and Interpretation of Safety Data
  Chapter  12  Exposure
  Chapter  13  Demographics and Other Baseline Characteristics
  Chapter  14  Disposition
  Chapter  15  Adverse Events Part 1: Common Adverse Events
  Chapter  16  Adverse Events Part 2: Deaths, Other Serious Adverse Events, Other Significant Adverse Events, and Analysis of Adverse Events by Organ System or Syndrome
  Chapter  17  The Analysis of Laboratory Data
  Chapter  18  The Analysis of Vital Signs, Physical Findings, and Other Observations Related to Safety
  Chapter  19  The Analysis of Electrocardiograms
  Chapter  20  Safety in Special Groups and Situations – Intrinsic Factors, Extrinsic Factors, and Drug Interactions
  Chapter  21  Use in Pregnancy and Lactation
  Chapter  22  Overdose
  Chapter  23  Drug Abuse
  Chapter  24  Withdrawl and Rebound
  Chapter  25  Effects on Ability to Drive or Operate Machinery or Impairment of Mental Ability
  Appendix  1  Introducing Mepro – A Fictitious Drug
  Appendix  2  The Integrated Analysis of Safety for Mepro
  Appendix  3  Company Core Safety Information for MEPRO (Meproamine Dihydroacetate)
  Appendix  4  6-Month Periodic Safety Update Report - Mepro
  Appendix  5  Clinically Significant Criteria for Laboratory, Vital Signs, Body Weight, Body Mass Index, and Electrocardiogram Parameters

Michael J. Klepper, MD-President, Michael J. Klepper, MD, LLC, Research Triangle Park, North Carolina

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.

Barton Cobert, MD, FACP, FACG, FFPM-President, BLCMD Associates LLC, Westfield, New Jersey

Barton Lewis Cobert MD, FACP, FACG, FFPM has had a long career in the clinical practice of  Gastroenterology and Internal Medicine as well as, in the pharmaceutical industry specializing in drug safety and risk management. For over a decade he was Global Head of Drug Safety (side effects) for the Schering-Plough Research Institute and held similar positions for Novartis Consumer Health Inc. He has also worked in the information technology industry at Medidata Solutions. Dr. Cobert was born in New York City and received his BA from New York University and his MD from New York University School of Medicine. He is board certified in Internal Medicine and Gastroenterology.   He is a fellow of the American College of Physicians, the American College of Gastroenterology and the Faculty of Pharmaceutical Medicine (UK). He has written and lectured extensively both nationally and internationally on drug safety, side effects and the safe use of medications. He has written three books on drug safety including the Manual of Drug Safety and Pharmacovigilance which is used as a textbook in courses on drug safety.  Dr. Cobert is president of BLCMD Associated LLC, a drug safety and pharmacovigilance consulting company in Westfield, NJ.

Additional Titles by this Author
  • I think this book is a must read for everyone involved in decision making on safety labeling.  A wonderful book.  Thanks for writing it.

    Dr. med. A. Leander Fontaine
    Pharmiceutics LLC

  • This book is very well written. It's chapters are well organized, and the language used is straightforward (meaning not too technical). The authors provide easy to understand definitions and they support their opinions with sound, logical rationale as well as examples. Each chapter ends with a good, health set of citations for further reading.  It is a great tool, a great resource. I believe this book is a must have.
    5 Star Review

  • Just what I was looking for! A concise `how to' guide written in a plain, friendly style that demystifies health authority regulations and guidelines. Although I have company SOPs to follow, this book can help me (with my nonclinical background working in Drug Safety for a pharmaceutical company) process incoming information and interpret large amounts of safety data far more intelligently. I am particularly impressed with the various examples of `real' safety compilations the authors use to illustrate theory.
    5 Star Review

  • “Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk” demonstrates how clinical research books should be written, with a practical, straightforward and comprehensive explanation of the collection, preparation, analysis and interpretation of safety data.

    Norman M. Goldfarb
    Managing Director of First Clinical Research LLC

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