Microdosing: An Emerging Tool for Drug Development
Microdose studies are gaining increasing importance in clinical drug development as they have the potential to shorten time-lines and cut costs. A microdose study is one of a suit of exploratory studies intended to be conducted in early phase-I that involve limited human exposure, have no therapeutic intent and are not intended to examine clinical tolerability. Microdosing may help both patients and the pharma industry with earlier availability of new test drugs, reduced failure of compounds at later stages and reduce the cost of drug development. A new product development tool kit is urgently needed to improve predictability and efficiency. These studies are based on the availability of ultra sensitive analytical methods like accelerator mass spectrometry (AMS) and positron emission tomography (PET) to measure the drug and its metabolite concentrations in the range of picograms or even lower. Both these techniques rely on the assessment and analysis of the radio isotopes incorporated into the drug under study. With evolution of technology (more sensitive mass specs, advances in LC equipment) LC-MS/MS is becoming a viable alternative.