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Biomarkers and Surrogate Endpoints for Development of New Drug on Pulmonary Disease  

Seo, Jeong-Won (College of Pharmacy, Chungnam University)
Lee, Byung-Yo (College of Pharmacy, Chungnam University)
Chae, Jung-Woo (College of Pharmacy, Chungnam University)
Son, Chu-Young (College of Pharmacy, Chungnam University)
Kang, Won-Ku (College of Pharmacy, Catholic University of Daegu)
Chae, Han-Jung (Departments of pharmacology, Chonbuk Natianal University Medical School)
Kwon, Kwang-Il (College of Pharmacy, Chungnam University)
Publication Information
YAKHAK HOEJI / v.54, no.2, 2010 , pp. 75-90 More about this Journal
Abstract
Biomarkers are likely to be important in the study of various pulmonary diseases for many reasons. Research efforts in developing biomarkers and surrogate endpoints of lung diseases have resulted in the identification of new risk factors and novel drug targets, as well as the establishment of treatment guidelines. Government agencies, academic research institutions, diagnostic industries, and pharmaceutical companies all recognize the importance of biomarkers in new drug development and advancing therapies to improve public health. In drug development, biomarkers are used to evaluate early signals of efficacy and safety, to select dose, and to identify the target population. Identification of suitable end points not only would help investigators design appropriate clinical trials but would assist clinicians in caring for this patient population. Though the area of pulmonology has received much attention in the past decades, it still lags behind with regard to the development of biomarkers, particularly those of health effects and susceptibility. This review critically summarized several biomarker researches such as Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) study with objectives of identifying the parameters that predict disease progression of COPD, as well as biomarkers that may serve as surrogate end-points.
Keywords
pulmonary disease; biomarker; surrogate endpoint; critical path;
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