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
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