Speakers for this Event:
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Micro-radiotracer studies in humans that take advantage of the very high sensitivity of Accelerator Mass Spectrometry (AMS) provide new approaches to answering important questions in early clinical drug development.
A key interest is the ability to give a small dose of 14C-labeled drug intravascularly (intravenously) while giving a therapeutic oral dose of non-radiolabeled drug extravascularlly (e.g. oral, dermal, inhaled). The intravenous plasma concentrations of radiolabeled drug are tracked using AMS while the total drug concentration (labeled and unlabeled) is measured using conventional bioanalytical methods such as LC/MS/MS. From these measurements a good estimate of absolute bioavailability for the route of extravascular delivery can be obtained. However, this type of approach raises several questions from a regulatory point of view.
This webinar will review the requirements and practical considerations around preparation and parametric release of drug in a pharmacy clean room to be administered intravenously. In addition, the regulatory requirements around validation and quality control of AMS assays will be reviewed. The audience will have the opportunity to question experts involved in both parametric release of drug product and AMS analyses.
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