Radiolabeled ADME Studies

ADME studies provide a way to evaluate the bioavailability, tissue distribution, active metabolite formation, and elimination of test materials. By using a radiolabeled compound it is possible to investigate the metabolic and clearance pathways of the material under test. One main application of these studies is to support drug safety evaluation studies regarding the formation and clearance of the major circulating metabolites. Additionally, these studies may be conducted as mass balance assays as required by regulatory agencies such as the US EPA for pesticide evaluation.

In radiolabeled preclinical ADME studies, samples from plasma, urine, feces and bile are collected at designated intervals and the activity of the radiolabeled dose material is measured.  At the end of the study, all the data from the individual collection intervals are summarized and usually presented as a total mass balance related to the initial dose.  Often, additional data regarding the tissue distribution of the material in the whole animal is generated as well.

The results from these studies can be used to examine the pharmacological and toxicological data of in vivo testing and how these may be applied to the human model, such as designing a clinical mass balance study.

Radiolabeled ADME studies may be conducted nonGLP or according to GLP.  At Pacific BioLabs, study designs are flexible and are developed to meet the specific needs of individual development programs.  All testing complies with applicable Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations as needed.  Our animal facility is AAALAC accredited and USDA and OLAW compliant.

Preclinical ADME Services

  • Radiolabeled ADME (tritium and carbon-14)

Available Radiolabeled ADME species

  • Mouse
  • Rat
  • Rabbit
  • Guinea Pig

Radiolabeled ADME Routes of Administration

  • Oral
  • Subcutaneous
  • Intravenous
  • Intramuscular
  • Intraperitoneal
  • Topical

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