The Role of Exploratory Investigational New Drugs for Translating Radiopharmaceuticals into First-in-Human Studies

Journal of Nuclear Medicine

Sally W. Schwarz¹  Reiko Oyama¹ 

[1] Department of Radiology, School of Medicine, Washington University in St. Louis, St. Louis, Missouri Department of Radiology, School of Medicine, Washington University in St. Louis, St. Louis, Missouri Department of Radiology, School of Medicine, Washington University in St. Louis, St. Louis, Missouri

关键词: exploratory IND guidance;    eIND;    microdosing;    21 CFR Part 212;    first-in-human RP;   

DOI  :  10.2967/jnumed.114.146472

学科分类：医学（综合）

来源: Society of Nuclear Medicine

【 摘 要 】

The Food and Drug Administration has provided a mechanism to reduce time and resources expended on new pharmaceuticals, including radiopharmaceuticals, in order to identify the most promising agents for further development. The exploratory investigational new drug guidance describes early phase 1 exploratory approaches involving microdoses of potential drug candidates that are consistent with regulatory requirements while maintaining the safety needed for human subjects, allowing sponsors to move ahead more quickly with the development of new agents.

【 授权许可】

Unknown