Methods available for monitoring the safety of marketed drugs.
Spontaneous reports of suspected adverse reactions may be the only way of revealing very rare events but they present great difficulties of rational interpretation. Some of these problems may be overcome by the application of quantitative epidemiological technique to data describing drug exposure and medical outcomes. Formal pharmacoepidemiological studies of this sort have proved valuable in the interpretation of "signals" generated by spontaneous reports.
Hurn
B A
BA
Clinical Safety Surveillance Service, Welcome Research Laboratories, Beckenham, Kent, England.
D003625:Data Collection / Q000379:methods; D011358:Product Surveillance, Postmarketing / Q000379:methods