신약개발을 위한 바이오이미징 기술의 동향 파악 및 발전 방안

• Published in: Yaghag-hoi-ji Vol. 62; no. 4; pp. 262 - 273
• Main Authors: 이종구(Jong Gu Lee), 김승희(Seung Hee Kim), 김정곤(Jeong Kon Kim), 김경원(Kyung Won Kim), 조우리(Woo Ri Jo), 유선애(Sun Ae Ryu), 박지원(Zewon Park), 이정연(Jung-Yeon Yi), 김보라(Bora Kim), 오우용(Woo Yong Oh)
• Format: Journal Article
• Language: Korean
• Published: The Pharmaceutical Society Of Korea 30.08.2018; 대한약학회
• Subjects: 약학; clinical trials; new drug development; regulation; bioimaging
• ISSN: 0377-9556; 2383-9457
• DOI: 10.17480/psk.2018.62.4.262

With change of medical paradigm toward patient-focused and personalized medication, the focus has changedfrom treatment of diseases to prevention of diseases. Owing to the increase in chronic diseases and population aging, theKorean pharmaceutical market size has rapidly increased, making the pharmaceutical industry the next-generation strategicsector. However, when considering the scale of investments, has indicated very low success rate. In addition, it took verylong time to develop a new drug, leading to such undesirable outcomes (approval of small number of new drugs anddecreased productivity, compared to R&D investment). Therefore, the need for development of new drug developmentstrategies and introduction of new concept to increase the efficiency of the new drug development and to reduce the developmentcost has been highlighted. Accordingly, it is necessary to assure paradigm shift and coherent linking of pre-clinicaland clinical studies, in order to correctly select candidate drugs for clinical studies. In order to overcome limitations of clinicalstudies, developed countries have expanded supports and investments in development of techniques for clinical evaluationand improvement of clinical program. Techniques obtained from such activities will be primarily used in establishingregulatory requirements as well as international standards. One of such alternative techniques for clinical evaluations is“bioimaging technique”. The bioimaging technique is a non-invasive technique to show living organism's structural andfunctional images. It can visualize normal biological processes, pathological processes and pharmacological responses totreatments and enable objective measurement and evaluation. It includes X-ray, CT, MRI, PET and others widely used inmedical examinations. In this study, the bioimaging technique and its utilization are carefully investigated and regulatorytrends in foreign countries are analyzed to identify current status in Korea. In addition, suggestions have provided to activateresearch of bioimaging technique in Korea and improve the system for review and evaluation of medicinal products. KCI Citation Count: 0