폐질환 치료제의 효율적인 신약개발을 위한 생체표지자 및 대리결과 변수

• 영문명: Biomarkers and Surrogate Endpoints for Development of New Drug on Pulmonary Disease
• 발행기관: 대한약학회
• 저자명: 서정원(Jeong-Won Seo) 이병요(Byung-Yo Lee) 채정우(Jung-Woo Chae) 손추영(Chu-Young Son) 강원구(Wonku Kang) 채한정(Han-Jung Chae) 권광일(Kwang-il Kwon)
• 간행물 정보: 『약학회지』제54권 제2호 (2010년), 75~90쪽, 전체 16쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2010.04.30

영문 초록

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.

키워드

pulmonary disease biomarker surrogate endpoint critical path