7 The Mathematics of Adverse Events and a Brief Note on Pharmacoepidemiology This chapter is not intended to be a reference on statistics, epidemiology, or the technical mathematical aspects of…
43 SOPs, Working Documents, Manuals, Guidelines United States, European Union, and other health authority regulations require that companies have written standard operating procedures (SOPs) to handle drug safety and pharmacovigilance….
12 AE Volume, Quality, Good Documentation Procedures, and Medical Records In spite of all the difficulties inherent in the system for collecting and analyzing Adverse Events (AEs), the number of…
9 Regulations, Directives, Guidances, and Laws Pharmacovigilance (PV) is governed by a large body of requirements. Some are written and rigid. Others are written and far less rigid. Others are…
25 Health Canada/Santé Canada Health Canada is the federal department in the Canadian government responsible for health matters, including pharmacovigilance. Their remit includes foods, drugs, devices, and many other areas…
6 Acute and Chronic (Late Occurring) Adverse Events, Adverse Events That Disappear (Bendectin), and Diethylstilbesterol Adverse events (AEs) seen shortly after starting or stopping drugs are common and relatively easy…
11 Drug Interactions Analyzing AEs and ascribing the causality to a particular drug can be quite difficult. This difficulty, however, is magnified when the patient also takes additional drugs. This…
3 Spontaneous Postmarketing Adverse Events Their pivotal and irreplaceable role in providing safety information when a wider population is exposed to a new product. Before a drug comes to…
4 The Theory of Drug Safety (Pharmacovigilance) Why a company needs a drug safety group and how it is constituted. The mission of a drug safety group within a pharmaceutical…
10 Children, Elderly, and Other Special (Vulnerable) Groups Background Similar to the testing of new drugs in pregnant women, the testing of drugs in special (“vulnerable”) groups poses issues. Special…
