Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory
Chapter 3Spontaneous Post-marketing Adverse Events
Chapter 4The Theory of Drug Safety — Pharmacovigilance
Regulations, Laws, and Guidances
The United States Regulations and Guidances
The European Union Legislation (including Directives and Regulations), and Guidance
Chapter 5The Mathematics of Adverse Events and a Brief Note on Pharmacoepidemiology
Case Report or Individual Case Safety Report
Why We Can’t Calculate Good Rates
Quantitative Signal Detection Methods
Chapter 6Epidemiology and Pharmacoepidemiology: What Are They?
What Are Their Limitations and Advantages?
Chapter 7Regulations, Directives, Guidance, Laws and Consensus Documents
Chapter 8The United States Food and Drug Administration