AME Studies (Absorption, Metabolism, and Excretion)
Radiolabeled studies are also known as AME studies (Absorption, Metabolism, and Excretion) because of what they measure.
For these types of studies, 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.
More on Radioactivity
- Exposure to radioactivity can be measured in units called millerem (mrem). The amount of environmental radiation exposure is dependent on a number of factors and will vary from place to place. For example, here in Madison, WI where these AME studies take place we know the background radiation level is 360 mrem/year.
- The 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 3-month washout period between AME studies at our clinic, however each study may dictate their preferred washout period.
- At Covance we have a team of Doctors and Scientists who are able to calculate 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.
Facts VS Fiction
- Will I glow in the dark if I take a radioactive drug?
- No! Radioactivity is invisible to the naked eye.
- Will radioactivity make me grow a third arm?
- Radioactivity at the doses we administer will not change your appearance. The doses we do administer do have the potential to cause birth defects when a developing child is exposed in large quantities. Therefore, we place very important birth control restrictions for each study to prevent any such events from occurring.
- Will I feel the radiation inside me?
- Nope! The only thing you will feel are the standard study procedures such as discomfort from a blood draw.
- Am I a risk to friends and family once I return home?
- The amount administered is so low that by the time you leave the clinic you would be considered safe to your friends, family, and the environment.
- Will there be any lasting effects from the radiation?
- The amount administered is so low that the exposure is much less than you would receive on an annual basis from your normal environment.
AME studies and BANANAS? Putting Things into perspective
Yes, bananas! Radiation is everywhere in the environment, including the foods we eat. For example, eating 1 banana will expose you to 0.01 mrem of radioactivity due to the radioactive potassium that is naturally occurring in the fruit. Normal daily activities can expose you to radioactivity so let’s take a look at different exposures in terms of bananas.
When you fly in an airplane, you are exposed to radioactivity in the atmosphere. The higher the altitude, the less shielding you will get from the atmosphere so the higher the exposure. Flying at an altitude of 33,000 ft for 1hr, your radiation exposure is estimated to be ~0.1 mrem (banana x 10).
A routine dental x-ray will expose you to ~0.5 mrem of radioactivity (banana x 50).
The annual radiation exposure by living in Madison, WI is 360 mrem/year (banana x 36,000). In comparison, the average exposure per study is (banana x 36,000).
To put these exposures into perspective, acute radiation sickness would take a dose of ~100,000 mrem of radioactivity (banana x 10,000,000)
The most radioactive place on earth? A smoker’s lungs. The annual exposure of radioactivity to a smoker’s lungs is ~16,000 mrem/yr. That’s like eating 1.6 million bananas!
Get started today. Fill out a brief form and we'll follow up to see if you qualify for a study. Or call us directly at 866-429-3700.