Accelerator Mass Spectrometry and Positron Emission Tomography in Human Microdosing
Pharmaceutical Sciences Encyclopedia December 16, 2011 Zhengdong Cheng
Human microdosing is an exploratory phase I investigation supported by U.S. and European regulatory agencies. It uses very small subpharmacologic doses of a drug in humans to obtain an early assessment of pharmacokinetic properties. This approach can reduce the number of preclinical animal studies, help differentiate between good and bad candidate drugs early, and speed up early phases of drug development. Human microdosing is a newly established and still evolving concept, with knowledge beginning to accumulate.