Using Radiolabeled CTMs in Early Phase Development

While the requirements for using traditional “cold” clinical trial materials are well understood, radiolabeled drugs come with a few special regulatory and development hoops. For starters, attaching the radioactive isotope to your CTM sometimes involves developing a new synthetic pathway, a process that requires CMC expertise and a deep understanding of organic chemistry. Once synthesized, radiolabeled drugs often exhibit different stability and impurity profiles which must be understood to ensure these changes don’t impact the validity of the study. These and other issues present special challenges related to CGMP compliance and patient safety during the clinical trial.

 

ABC Laboratories will expand on this important topic at the 12^th International Symposium on the Synthesis and Application of Isotopically Labelled Compounds on the campus of Princeton University June 7-11. Join Wayland Rushing, Ph.D., ABC Senior Scientific Advisor at # AM/PM June 11 for a podium presentation titled, “CGMP Radiosynthesis for Early Clinical Trials: A Unique Challenge.”