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

by Klepper, Michael J.; Cobert, Barton

• ISBN13: 9780763769123
• ISBN10: 0763769126
• Edition: 1st
• Format: Paperback
• Copyright: 2010-09-29
• Publisher: Jones & Bartlett Learning

Summary

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)

Table of Contents

Part1 The Basics
Chapter1 Benefit-Risk
Chapter2 Begin at the End
Chapter3 The "Dynamic" Integrated Safety Database - Something You Shouldn't Live Without
Chapter4 Coding Basics
Chapter5 Determining Causality - The Individual Case Safety Report
Chapter6 Determining Causality - Aggregate Data
Chapter7 Determining the Weight of Evidence - Patterns and Links
Chapter8 Determining Clinical Significance…and Then What?
Chapter9 Clinical Laboratory Tests - What Is Measured; What It Means
Chapter10 12-Lead Electrocardiograms - What Is Measured; What It Means
Chapter11 Adverse Events That Should Be on Everyone's Radar Screen
Part2 Approaches to the Analysis, Summary, and Interpretation of Safety Data
Chapter12 Exposure
Chapter13 Demographics and Other Baseline Characteristics
Chapter14 Disposition
Chapter15 Adverse Events Part 1: Common Adverse Events
Chapter16 Adverse Events Part 2: Deaths, Other Serious Adverse Events, Other Significant Adverse Events, and Analysis of Adverse Events by Organ System or Syndrome
Chapter17 The Analysis of Laboratory Data
Chapter18 The Analysis of Vital Signs, Physical Findings, and Other Observations Related to Safety
Chapter19 The Analysis of Electrocardiograms
Chapter20 Safety in Special Groups and Situations - Intrinsic Factors, Extrinsic Factors, and Drug Interactions
Chapter21 Use in Pregnancy and Lactation
Chapter22 Overdose
Chapter23 Drug Abuse
Chapter24 Withdrawl and Rebound
Chapter25 Effects on Ability to Drive or Operate Machinery or Impairment of Mental Ability
Appendix1 Introducing Mepro - A Fictitious Drug
Appendix2 The Integrated Analysis of Safety for Mepro
Appendix3 Company Core Safety Information for MEPRO (Meproamine Dihydroacetate)
Appendix4 6-Month Periodic Safety Update Report - Mepro
Appendix5 Clinically Significant Criteria for Laboratory, Vital Signs, Body Weight, Body Mass Index, and Electrocardiogram Parameters