Pharmacovigilance and pharmacoepidemiology

The principal methods of collecting data on adverse reactions (pharmacovigilance) are:

• Experimental studies, i.e. formal therapeutic trials of Phases 1-3. These provide reliable data on only the commoner events as they involve relatively small numbers of patients (hundreds); they detect an incidence of up to about 1:200.

• Observational studies, where the drug is observed epidemiologically under conditions of normal use in the community, i.e. pharmacoepidemiology. Techniques used for postmarketing (Phase 4) studies include the observational cohort study and the case-control study. The systems are described on page 69.

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