Microdosing

Currently, the pharmacokinetics of potential new drug compounds is determined through screening in animals (pre-clinical research). The compound is also tested, typically concurrently, for safety and toxicology in animals. If all the pre-clinical results seem suitable for humans, then the compound progresses to the first human clinical trials. However, findings from the initial human trials often result in a compound being rejected immediately as a possible therapy. To reduce the number of animal experiments required to support a drug development program, the technique of microdosing has been proposed.

Microdosing involves administering a sufficiently small dose of the test compound to humans such that it will not produce any pharmacologic effect or adverse reaction. The path of the radio-labelled drug in the body is monitored using accelerator mass spectrometry. A microdose may provide sufficiently useful pharmacokinetic information to help decide whether it is worth continuing with compound development and the associated animal-based tests. Appropriately used, this technique could reduce the number of ultimately unwanted drugs going through safety and toxicology testing in animals.

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