FDA exploratory IND의 기준을 중심으로 본 국내 방사성 의약품 기술개발을 위한 제언

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.