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
- 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.
- 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
- 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
About the Authors
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 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.
Product Details
- Paperback: 316 pages
- Publisher: Jones & Bartlett Learning; 1 edition (2011)
- Language: English
- ISBN-10: 0763769126
- ISBN-13: 978-0763769123
- Product Dimensions: 10.8 x 8.4 x 0.8 inches
List Price: $87.95