FDA exploratory IND의 기준을 중심으로 본 국내 방사성 의약품 기술개발을 위한 제언
(Suggestions for Radiopharmaceutical Drug Development in Korea Focusing on FDA Exploratory IND Guideline) |
| Author |
유영훈1·최태현2, |
| Young Hoon Ryu, M.D., Ph.D.1 and Tae Hyun Choi, Ph.D.2 |
| Affiliation |
연세대학교 의과대학 영상의학교실 핵의학과1, 한국원자력의학원 방사선의학연구소 핵의학 RI 연구부, 동위원소생산평가기술개발팀2
1Department of Nuclear Medicine, Yonsei University, Medical College, Seoul, Korea. 2Radiological and Medical, Sciences Research Center, Korea Institute of Radiological and Medical Sciences, Seoul, Korea |
| Abstract |
Regulation for the radiopharmaceuticals should be reasonably different from that of other drugs. Radiopharmaceuticals are always used by compounding based on the doctor's order, have short half life and very low administration dose. Its pharmacological effect is not from its chemical effect but from radiation. The background for exploratory IND (Investigational New Drug) explained by the FDA was to reduce the time and resources expended on candidate products that are unlikely to suceed, new tools are needed to distinguish earlier in the process those candidates that hold promise from those that do not. In this review, basic concept for exploratory
IND and RDRC guideline is summarized and various suggestions for improving and expediting procedure for new radiopharmaceutical development would be described. (Nucl Med Mol Imaging 2007;41(6):525-529) |
| Keyword |
radiopharmaceutical, drug development, investigational new drug, microdose |
| Full text Article |
4106529.pdf 
|
|
|
