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In an effort to reduce the number of potential drugs that fail during clinical development, drug companies are increasingly looking to human microdosing.
In an effort to reduce the number of potential drugs that fail during clinical development, drug companies are increasingly looking to human microdosing. The aim is to use ultrasensitive methods such as accelerator mass spectrometry and microgram quantities of drugs to conduct full human metabolism studies. Accelerator MS is one of the most precise bioanalytical approaches available. This session will cover topics such as the technologies involved in human microdosing clinical studies, quantification and identification of metabolites at microdosing levels, and combination techniques for detection of total recovery information.
The introduction to the session will be given by Graeme Young of GlaxoSmithKline, and is titled “A Review of the State-of-the-Art of Human Microdosing and Nanotracer Studies — As an Introduction to the Session.” Young will focus on the enabling technologies for support of innovative clinical study designs.
Next up will be Brad Keck, of Vitalea Science (Davis, California), who will present “Absolute Quantitation Without Internal Standards: Accelerator Mass Spectrometry and Microtracers for Pharmacokinetics and Metabolite Discovery.” Keck’s presentation will explain how accelerator mass spectrometry can provide absolute abundance data for any 14C-tagged metabolite at attomole levels of detection without internal standards.
The third topic, presented by Carmai Seto of MDS Analytical Technologies (Concord, Canada), is “Quantification and Identification of Metabolites at Microdosing Levels.” This talk will cover the use of a new fast-scanning, high-sensitivity hybrid mass spectrometer to identify metabolites at microdosing levels.
Following this presentation, Giacomo Jason of Vitalea Science (Davis, California) will discuss “Single Instrument AMS and IRMS for Microdose/Microtrace Mass Balance Studies,” which will discuss the benefits of using combination AMS and IRMS to obtain high total recovery information over long periods of time.
The fifth talk, “Early Investigation of Human Metabolism in Drug Development,” will be given by David S. Wagner (GlaxoSmithKline). Wagner will discuss how mass spectrometry can be used to obtain critical information from human studies early in drug development.
Finally, Leon Coulier of TNO Quality of Life (Zeist, The Netherlands) will present “Comprehensive Analysis of (Phosphorylated) Nucleoside Reverse Transcriptase Inhibitors and Endogenous Deoxynucleotides in Plasma and PBMCs Using (Ion-Pair) LC–MS-MS.” This talk will focus on the use of a comprehensive multi-target LC–MS-MS platform for extremely polar endogenous and drug metabolites at very low clinical concentrations.