ABC Presents This Week at Princeton University: CGMP Radiosythesis for Early Clinical Trials
Columbia, Missouri – 06/09/15 While the requirements for using traditional “cold” clinical trial materials are well understood, radiolabeled drugs come with a few special regulatory and development considerations. 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; to ensure the validity of studies, these must be understood. These and other issues present special challenges related to CGMP compliance and patient safety during the clinical trial.
ABC Senior Scientific Advisor, Wayland Rushing, Ph.D., will expand on this important topic at the 12th International Symposium on the Synthesis and Application of Isotopically Labelled Compounds on the campus of Princeton University Wednesday, June 11 at 10:30 AM.
For additional information, contact Kristein King at 573-777-6209.