In an AME study, the study drug is specially prepared to contain radiolabeled carbon or tritium (found in soil, rocks and air). Adding a low dose of radiation to the study drug does not change how the drug works but helps us to see how the drug appears in body fluids such as blood, urine and stool after it is given to you.
What do I need to know about radiolabeled studies?
- Exposure to radioactivity can be measured in units called millerem (mrem). The amount of environmental radiation exposure depends on a number of factors and will vary from place to place. For example, here in Madison, Wisconsin, where these AME studies take place, we know the background radiation level is 620 mrem/year
- The Food and Drug Administration (FDA) sets limits as to the amount of radioactivity that a research subject can be exposed to on a per study basis and over a given year
- Maximum whole-body radiation exposure = 5,000 mrem/year; 3,000 mrem/study. We have a mandatory three-month washout period between AME studies at our clinic; however, each study may dictate their preferred washout period
- Our team of doctors and scientists calculates how much radioactivity you would be exposed to during a study to ensure that you are exposed to limits much lower than what is set forth in the FDA regulations