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Radiolabelled Materials Working Group
Human radiochemical excretion and metabolism studies are a standard aspect of small molecule drug development. New technologies such as accelerator mass spectrometry (AMS) and new study designs, sometimes involving administration of much lower doses of radioactivity, have resulted in varying opinions about the regulatory requirements for the synthesis of the radiochemical component of a radioactive formulation.
The goal of this Working Group is to gain understanding of how the IQ member companies prepare and characterize GMP radiolabelled small molecule candidates for use in Human absorption- distribution- metabolism-elimination (ADME) studies.