Don't get caught in a regulatory hot seat: Using Radiolabeled CTMs in Early Phase Development

Studies conducted using 14C-radiolabeled clinical trial materials (CTMs) result in detailed DMPK, ADME and mass balance information, providing great insight into a drug’s behavior in vivo. While CMC requirements for traditional “cold” clinical trial materials (CTMs) are well understood, successfully incorporating “hot” or “blended” versions of drugs into your development plan requires specialized expertise.

Hot Challenges

Attaching the radioactive isotope to your CTM sometimes involves developing a new synthetic pathway—a process that requires radiochemistry expertise and rigorous CGMP-compliant facilities, processes and systems.

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