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PHARMACOKINETICS AND RADIOLABELED ADME

Pharmacokinetics (PK)

Pharmacokinetic studies are used to gather information on how a drug compound moves through and is processed by the body. This includes the absorption, distribution, metabolism, and excretion (ADME) of a drug.

These studies provide useful feedback for formulation scientists. PK studies yield parameters such as AUC (area under the curve), Cmax (maximum concentration of the drug in blood), and Tmax (time at which Cmax is reached). Later on, data from animal PK studies can be compared to data from early stage clinical trials to check the predictive power of animal models.

ADME and Radiolabeled ADME

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 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. 

ADME and PK 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.

Test Categories

• Pharmacokinetics (PK)
• Mass Balance
• Tissue Distribution
• Bioequivalence (formulation support)
• Radiolabeled ADME (tritium and carbon-14)

Available species

• Mouse
• Rat
• Rabbit
• Guinea Pig
• Dog
  

Routes of administration

• Oral
• Intravenous
• Intraperitoneal
• Topical