The Australian method of drug-event assessment. Special workshop--regulatory.
In the Australian system, the major aim is to test individual reports for quality, judged entirely by the contents of the report. Prior knowledge of the adverse drug reaction profile of the drug is excluded. The items taken into account include timing (onset of the reaction), setting (nature of the disease, drugs, and diet), and laboratory information.
D001315:Australia; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008722:Methods; D011358:Product Surveillance, Postmarketing / Q000592:standards