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KMID : 1142220140090020123
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 2 p.123 ~ p.131
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Guideline on Clinical Evaluation of New Medicinal Products in the Treatment of Chronic Obstructive Pulmonary Disease
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Seo Hyun-Ok
Kim Ji-Young
Baek Ju-Hyun
Park Hee-Kyung
Lim Hwa-Kyung
Kang Ju-Hye
Choi Ki-Hwan
Lee Sun-Hee
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Abstract
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Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disorder characterized by airflow limitation that is not fully reversible. As increased the prevalence of COPD, development for new drug in the treatment of COPD is actively investigated. This study is intended to provide guideline on clinical evaluation of new drugs for COPD. The main consideration of clinical trials’ design for COPD, subject inclusion and exclusion criteria, efficacy and safety end points etc., is suggested in this study. This guideline might be helpful to both developers and reviewers
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KEYWORD
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chronic obstructive pulmonary disease (COPD), clinical trial, guideline
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