souseikai global clinical research center

Microdose Studies

In order to study the process of new investigational drugs in humans, administration of very low doses of the drug can be a reasonal first step.
By the selection of an optimal dose that is unlikely to produce whole-body effects but high enough to observe the cellular responses, you can estimate the pharmacokinetics of the drug with a minimum risk of adverse events.

The term microdose is defined as a 1/100th of the clinical doses as determined from animal studies, or 100 μg of the drug. Because the nature of the microdose requires sophisticated and trained techniques, finding an experienced investigational site will govern the fate of the clinical trial.

Since our first microdose study using 14C radiolabeling and AMS was conducted in 2009 at our clinical research center, we have conducted 8 protocols with 154 subjects as of 2016.

We help our clients save both time and money, getting quick estimates about investigational drug efficacy at a very early stage of the drug's development.

If you are interested in microdose studies Contact us here.