The Food and Drug Administration Algorithm: Special Workshop—Regulatory
The Food and Drug Administration Algorithm: Special Workshop—Regulatory
复制标题
食品药品监管算法：专题研讨会——监管
DOI：
10.1177/009286158401800311
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发表时间：
1984
影响因子：
1.5
通讯作者：
W. M. Turner
中科院分区：
文献类型：
--
作者：
W. M. Turner
The Food and Drug Administration presently receives and evaluates over 40,000 case reports of adverse drug effects a year. Each report is objectively reviewed and evaluated. A causal association assessment between each drug and reaction is made. The objective causal assessments are based on four basic principles: (a) temporal eligibility, (b) dechallenge and outcome, (c) rechallenge and outcome, and (d) confounding factors. This presentation introduces the algorithm used by the FDA Division of Drug Experience and provides the basic information needed to use the FDA algorithm for making causal relationship assessments.
