Accelerator Mass Spectrometry and Positron Emission Tomography in Human Microdosing
Pharmaceutical Sciences Encyclopedia December 16, 2011 DOI: 10.1002/9780470571224.pse429 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | Microdosing |
| Key findings | Human microdosing can reduce preclinical animal studies, help differentiate candidate drugs early, and speed up early drug development phases. |
Abstract
AbstractHuman microdosing study is one type of exploratory phase I investigation supported by both U.S. and European regulatory agencies. Very small subpharmacologic doses of a drug are used in humans to obtain an early assessment of pharmacokinetic properties in humans. This has the potential of reducing the number of preclinical animal studies, essential for conducting early clinical human studies, differentiating between good and bad candidate drugs early, and speeding up the early phases of drug development. Human microdosing, as will be outlined in this chapter, is a newly established and still evolving concept, around which knowledge is beginning to accumulate.