Before a drug can be approved for marketing and offered to patients, it must be extensively studied in nonclinical and clinical studies to demonstrate its safety and efficacy. Excretion and mass balance studies provided by BOC Sciences investigated the absorption and excretion of the drug after a single dose in subjects. The drug is radiolabeled to determine drug disposition and assess major metabolic pathways. Each study is tailored to the specific challenges unique to each project.
Introduction to Excretion and Mass Balance Studies
Mass balance studies are also known as absorption, distribution, metabolism and excretion (ADME) studies. Mass balance refers to collecting as much radiolabel as possible from human subjects in a clinical study. Radiolabeling is derived from excreta, including urine, feces, exhaled air, sweat, etc., while detecting exposure to radioactivity and drugs in whole blood, plasma, cerebrospinal fluid or other tissues of interest. The goal of excretion and mass balance clinical studies is to understand the excretion process of a drug after administration. Information on excretion and mass balance helps determine what additional clinical studies may be required for regulatory approval of a new drug.
Why Do Excretion and Mass Balance Studies
- To study the balance of substances and compare the dose and recovery of radioactive administration
- To study elimination pathways and the extent of absorption
- To study metabolites in circulation and excreta
- To study the clearance mechanism of drug
- To study the exposure of prototypes and metabolites
- To validate the rationality of animal species used for toxicological testing
- To explore whether metabolites have an impact on pharmacological or toxicological effects
