Mass Balance Studies
Creative Animodel is a leading company specialized in new drug discovery and development. We can provide a comprehensive process for in vivo and in vitro drug metabolism and pharmacokinetic studies, including the integrated process of mass balance studies. Our team of experts with extensive experience can help you understand what you are trying to investigate and give you the most appropriate solutions. Our company strives to stay ahead of the changing research landscape. For drugs that are difficult to analyze with traditional mass balance procedures, our scientists also can provide the appropriate method such as accelerator mass spectrometry (AMS) to support your research.
What Can We Learn from a Mass Balance Study?
Mass balance study is a method to determine the absorption, metabolism, and excretion (AME) characteristics of a drug, which refers to balancing the amount of drug administered to the amount of drug-related material collected excreta (normally feces and urine, but expired air and sweat also involved). The primary objectives of mass balance study:
• To determine the absorption of drug after administration.
• To identify excretory pathways in early stages of drug development.
• To characterize the PKs of the intact parent drug and its metabolites.
• To determine clearance mechanisms, including metabolic and excretory fates and understand potential contributors of inter subject variability associated with drug–drug interactions (DDIs).
• To determine the organs/tissues distribution in preclinical species.
How Do We Perform a Mass Balance Study?
• A radioactive label (usually 14C) is incorporated into a drug before the drug administering.
• During the circulation (before the administered radioactivity is recovered in the excreta), blood, plasma, urine, and feces require accurate collected from the study subjects.
• The excreta and blood samples gathered in such studies are identified and quantified profiling of metabolites and parent drug by sensitive radiometric detection methods (liquid scintillation or accelerated mass spectroscopy).
Thus, the amount of “radioactivity” in the original dose can be compared to the amount of radioactivity in the excreta to calculate the mass balance. Since radioactivity measurements are independent of drugs’ chemical structure, total radioactivity measurements can be thought of as “parent + all metabolites”. Furthermore, the presence of the “label” has no impact on the identification of metabolites by LC/MS-MS methods combined with radiometric detection.
• Over 90% recovery ratio
• Ultrasensitive detection radiocarbon analysis
• Air pathway provided
• Richer Data Types (including PK parameters, concentration-time curves, cumulative recovery curves etc.)
Creative Animodel has innovative study designs, optimal facilities and strong regulatory intelligence, all of which will help our clients get high-quality results with lower cost and less time. A properly designed mass balance study will allow you to target address the main objectives with lower investment. Please contact us for further support in the development of your drug.