KMID : 1142220150100020165
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Regulatory Research on Food, Drug & Cosmetic 2015 Volume.10 No. 2 p.165 ~ p.169
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The Status of the Authorization of Anticancer Agents and Approval of Clinical Trials for Cancer Therapies in Korea for the Recent 3 Years (2012~2014)
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Jeon Seol-Hee
Kim Ji-Eun Um Jung-Yoon Park So-Ra Kim Mi-Jie Kim Dong-Hwan Kim So-Hee Han Eui-Sik Lee Sun-Hee Yoon Kyung-Eun
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Abstract
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The domestic and global oncology drugs markets are rapidly changing along with the ever-developing science technologies. In line with, the article analyzes the status of the authorization of anticancer agents and approval of clinical trials for cancer therapies in Korea for the recent 3 years (2012-2014). This will provide cancer patients with new and recent information and support researchers of anticancer agents. From 2012 to 2014, newly authorized anticancer agents were the following: 35 substances and 130 products including 7 substances and 12 products for new drugs. Specifically, there were 12 substances for targeted therapy, 13 for cytotoxic therapy, 6 hormonal therapy and 4 for immunotherapy. For the same period, 347 clinical trials were approved in Korea. Among them, 233 clinical trials are about targeted therapy, 90 are about cytotoxic therapy and 11 are about hormonal therapy. In the past three years, targeted therapy had been preferred to cytotoxic therapy and the trend could be found in the clinical trials for cancer treatment approved in Korea.
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KEYWORD
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anticancer agents, the status of drug authorization and clinical trial approval in Korea, targeted therapy, cytotoxic therapy
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