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KMID : 1142220140090020133
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 2 p.133 ~ p.140
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Clinical Strategy in the Development of Fixed Dose Combination Drugs
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Seo Hyun-Ok
Lim Sook
Kang Ju-Hye
AHn Choong-Yul
Oh Woo-Yong
Choi Ki-Hwan
Lee Sun-Hee
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Abstract
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Although the fixed dose combination drugs (FDC) have been developed for more than 10 years, there is not a guideline about general consideration for developing them in Korea. There are several scientific guidelines on FDC, however, they are limited on specific diseases. Therefore the necessary to explain general guideline for FDC has been raised. The goal of this study is to provide principles on planning and designing clinical trials for FDC. In this study, the developing purpose of FDC is divided into three categories, and types of clinical trials by the categories are described. This results could be useful to make a clinical strategy in the development of FDC without restriction on disease.
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KEYWORD
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fixed dose combination drug (FDC), clinical trial, guideline
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