In the last two decades, Accelerator Mass Spectrometry (AMS) has developed from being a little known niche technology, only used as a last resort in drug development, to a more mainstream analytical tool that facilitates flexible clinical study designs, providing deep insights into the pharmacokinetics and metabolic fate of new drugs. GSK has lead the Pharmaceutical Industry in the application and development of AMS, including being unique in having established an in-house AMS capability over 10 years ago. The presentation will reflect upon the expanding scope of AMS over recent years to encompass experiments designed to yield previously unattainable data, with particular emphasis on human ADME and intravenous microtracer studies (see image attached as summary). The latter of these designs is as yet underutilised in drug development and yet the data provided can be extremely insightful in providing direction for the course of drug development. Technical aspects of AMS application through the coupling of chromatography as a separation technique to allow quantification of analytes at exquisite sensitivity has been achieved and aided experimental design with valuable results obtained. Examples will be given of such experiments.<br/>The ongoing and future development of AMS, as well as the emergence of techniques as potential alternatives to AMS to provide deep insight into the research of new medicines will also be discussed.

AMS enabled clinical studies in GSK: Past, present and future

253rd National Meeting (2017)

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