Drug evaluation after marketing.

Abstract:

:After marketing, drugs should be evaluated for safety and for efficacy. Present national systems are inadequate for both tasks. Safety can be evaluated by means of nonexperimental research, whereas evaluation of efficacy in a variety of settings representing normal medical practice generally requires experiments, randomized and blinded. Research into safety requires the maintenance of routine, yet flexible, multipurpose data systems, different for established and newly marketed drugs. Ad hoc studies on safety and on efficacy can be mounted more swiftly and economically through the maintenance of "standby" capabilities, in addition to maximal use of resources outside the actual national system.

journal_name

Ann Intern Med

authors

Slone D,Shapiro S,Miettinen OS,Finkle WD,Stolley PD

doi

10.7326/0003-4819-90-2-257

subject

Has Abstract

pub_date

1979-02-01 00:00:00

pages

257-61

issue

2

eissn

0003-4819

issn

1539-3704

journal_volume

90

pub_type

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