This webinar will be presented by the IQ Radiosynthesis Working Group and open to IQ member companies.
Human radiochemical absorption, distribution, metabolism and excretion (ADME) studies are a standard aspect of most small molecule drug development programs. Over the last 20 years, and especially in the last 5 years, significant technological advances in bioanalysis and changes in industry practices have had the potential to impact the Chemistry, Manufacturing and Controls (CMC) aspects of clinical radiotracer trials in human subjects.
To define current industry practices for the synthesis of radioactive API for use in human ADME studies, the API, Analytical, and Drug Metabolism Leadership Groups within the International Consortium for Innovation and Quality in Pharmaceutical Development (The IQ Consortium) recently conducted a cross-disciplinary survey of radiosynthesis practices in 28 IQ Consortium Member Companies. The webinar will summarize survey results that revealed many common practices for synthesis of radiolabeled API that enable the delivery of high quality radiochemical formulations for clinical use.