Reduction Alternatives
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.
This section has been adapted from Rowland (2006).
For more information on microdosing, the following resources may be useful:
- Anon. (2005) Human microdosing reduces the number of animals required for pre-clinical pharmaceutical
research. ATLA 33:439.
- Lappin G. & Garner R. (2003) Big physics, small doses: the use of AMS and PET in human microdosing of
development drugs. Nature Reviews Drug Discovery 2:233-240.
- Rowland M. (2006) Microdosing and the Three Rs. NC3Rs.
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