研究性药物与研究
Investigational drugs and research.
作者信息
Tueting P
机构信息
Office of Research Administration, Illinois State Psychiatric Institute, Chicago.
出版信息
Psychiatr Med. 1991;9(2):333-47.
PMID:1857767
Abstract
This chapter will define investigational use for clinicians and outline FDA policies in this area in a simple and pragmatic way. Instances in which investigational use would require application to the FDA for an investigational New Drug Exemption (IND) and instances in which their use would require approval by an Institutional Review Board (IRB) will be described and examples given.
摘要
本章将以简单实用的方式为临床医生界定研究性用途，并概述美国食品药品监督管理局（FDA）在该领域的政策。将描述研究性用途需要向FDA申请研究性新药豁免（IND）的情况以及其使用需要获得机构审查委员会（IRB）批准的情况，并给出示例。
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