Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk: How to Analyze, Summarize and Interpret to Determine Risk / Edition 1

by Michael J. Klepper, Barton Cobert

Overview

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)

Product Details

ISBN-13:	9780763769123
Publisher:	Jones & Bartlett Learning
Publication date:	09/29/2010
Edition description:	1E
Pages:	316
Product dimensions:	8.40(w) x 10.80(h) x 0.80(d)

About the Author

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 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.

Table of Contents

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 Lab oratory 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 Lab oratory 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 Lab oratory, Vital Signs, Body Weight, Body Mass Index, and Electrocardiogram Parameters