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Risk management of drug products in FDA: the development and implication
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作者 王宝敏 周林光 +2 位作者 李斌 杨松 江滨 《Journal of Chinese Pharmaceutical Sciences》 CAS CSCD 2015年第6期405-411,共7页
This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages: the launch of laws and regulations of drug risk management, ... This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages: the launch of laws and regulations of drug risk management, pre-market approval and post-market safety supervision, adverse drug reaction and risk communication. To address the problems existing in drug risk management in China, suggestions to further and improve the development of drug risk management are proposed. 展开更多
关键词 Drug risk management Drug safety Drug supervision FDA
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