Microdose Testing of New Drugs Will Speed Up Research on Needed Pharmeceuticals on the Market

Testing for new drugs is expensive and timely. According to the Food and Drug Administration most new drugs take about ten years to develop and cost, on an estimate, $1.7 billion dollars. However, in a new technique, the test subject ingests an amount of a drug that is so small it has no discernable effect – a tenth of a milligram or less. Blood samples are later analyzed by an instrument called an accelerator mass spectrometer, that recognizes and counts particular molecules with radioactive forms of the carbon atom, with which the tested drug has been labeled. This involves some transmission of radioactivity. However, the new technique, according to the FDA, exposes the research subject to minimal radiation, comparable to a cross-country airline flight.

The microdose drug testing is made possible now by new rules approved by the FDA in January of this year, for drug testing that permit human testing at a microdose level.

Microdose tests on humans are done after preliminary trials on rats or dogs. This eliminates a step where unnecessary, lengthy and involved human drug trials are conducted with compounds that may turn out to be unacceptable.

With the microdose testing, drugs on humans can be evaluated early on, and appropriately designed clinical trials, can be developed more quickly with less expense. In short, drugs that perform poorly in humans can be eliminated early in the research cycle. The first company to analyze these micro amounts is located in Woodland, Ca by the name of Vitalea Science Inc., founded by Stephen Dueker, a nutritional chemist and faculty affiliate at the UC Davis.