Accelerator Mass Spectrometry and Positron Emission Tomography in Human Microdosing
Pharmaceutical Sciences Encyclopedia December 16, 2011 DOI: 10.1002/9780470571224.pse429
Summary
AI-generated from the abstractHuman 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.
Study at a glance
| Characteristics | Review Peer reviewed |
|---|---|
| Dose | very small subpharmacologic doses |
| Key finding | 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.