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The risks of risk aversion in drug regulation

제어번호   62107684

저자명   Eichler, H. G.  , Bloechl-Daum, B.  , Brasseur, D.  , Breckenridge, A.  , Leufkens, H.  , Raine, J.  , SalmonsonT.  , Schneider, C. K.  , Rasi, G. 

학술지명   NATURE REVIEWS DRUG DISCOVERY

권호사항   Vol.12 No.12 [2013] 

발행처   Nature Publishing Group 

자료유형   학술저널

수록면   907-916    [※수록면이 p5 이하이면, Review, Columns, Editor's Note, Abstract 등일 경우가 있습니다.]

ISSN   1474-1776

언어   eng

발행년도   2013년

등재정보   SCI;SCIE;SCOPUS

http://www.riss.kr/link?id=O62107684

Abstract

Drugs are approved by regulatory agencies on the basis of their assessment of whether the available evidence indicates that the benefits of the drug outweigh its risks. In recent years, regulatory agencies have been criticized both for being overly tolerant of risks or being excessively risk-averse, which reflects the challenge in determining an appropriate balance between benefit and risk with the limited data that is typically available before drug approval. The negative consequences of regulatory tolerance in allowing drugs onto the market that turn out to be unsafe are obvious, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent. Here, we discuss the consequences of regulatory risk-aversion for public health and suggest what might be done to best align acceptance of risk and uncertainty by regulators with the interests of public health.