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FDA May Support New Testing Method for Drugs
Submitted on:
04.17.2008
The Critical Path Institute, founded two years ago by the U.S. Food and Drug Administration (FDA) to reverse a trend of fewer innovative therapies being submitted for approval and to improve drug safety, is poised to support a new method of predicting the safety of experimental drugs. The process being considered uses biomarkers to detect kidney injury when found in patients’ urine. Current testing methods do not indicate kidney injury until about 70 percent of kidney function is already lost, so the new biomarker process has the potential to save a patient's kidneys. The ultimate goal of the pharmaceutical industry is to have a range of such marker tests that would signal dangerous side effects like heart failure, liver damage or cancer in samples of blood, urine or saliva, for example, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.
Click here for the full article in the San Francisco Chronicle.
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