Scientists discovered a faster and better way to test the breakdown of drugs in the human body, increasing the speed of development, saving expenses, and alleviating the need for animal testing.

Drug development is a labor-intensive, time consuming and expensive operation - Image Credit: Gorodenkoff via Shutterstock / HDR tune by Universal-Sci

In order to get a new drug approved, all sorts of aspects of this drug have to be tested before it gets approved. One of the necessary testing components is how long it takes for our body to break it down. Recently scientists discovered a new faster and better way to do this.

Currently, tests for absorption, distribution, metabolism, and excretion of drugs in humans are often conducted in the late stages of drug development. When problems are discovered at a later stage of development, there's a tremendous risk that years of development unavoidably goes down the drain. It can be a daunting challenge for biotechnology companies to recover from these issues.

TNO (the Netherlands Organisation for applied scientific research) acquired an advanced microtracer technology capable of simultaneously providing so-called MIST and Mass Balance data with allows for directly identifying human metabolites much earlier in the drug's development process. Because metabolites can be identified so early, biotechnology companies no longer have to spend many years - and large sums of money - developing a drug that requires additional (and in fact unnecessary) toxicology studies.

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Using an Accelerator Mass Spectrometer (AMS) enables scientists to utilize microtracer dosing. Microtracing is an innovative technology in which minute quantities of substances are tested in humans. No more than 100 micrograms, or 30 nanomoles for proteins, are administered. This is less than one-hundredth of the expected therapeutic dose, a quantity that does not cause side-effects.

Additionally, the AMS also permits fully automated sample analysis, allowing samples to be processed in minutes instead of days. The automated procedure is also less labor-intensive and, therefore, much more inexpensive. Moreover, no substances need to be recovered, and the recovery time for human volunteers is much shorter.

In a microdosing study, minimal doses (<100 µg) are administered to human volunteers who are not physically affected by the drug. Still, the level of this microdosing is high enough to be measured in TNO's advanced AMS facility so that PK data can be collected from real people. This is more valuable than preclinical animal experiments and also means that less animal testing is needed.

Currently, a number of pharmaceutical companies are already using the new technology. TNO scientists hope that within five years, they will have convinced 80 to 90 percent of the industry to take this new drug development path.

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