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.
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.
We have many years of experience designing, conducting and interpreting excretion and mass balance studies. Our experienced staff has a deep understanding of pharmacokinetic data analysis and can provide our global clients with the following services:
It can take up to one to two years for the drug to be radiolabeled. It is recommended to work with a radiochemist early in the development program and before clinical ADME studies are required. This requires the placement of a radioisotope (14C preferred) in the molecular fraction which can be used for the parent drug and all relevant metabolites
Quantitative whole-body autoradiography (QWBA) was used to determine dosimetric calculations of allowable radiolabel doses for ADME studies in humans. This study avoids the research risk of radiolabeled drugs accumulating in sensitive tissues and causing toxicity or damage.
Proper planning around formulation development and production of adequate quantities of radiolabeled drug at the start of an R&D project.
Our qualified pharmacokineticists perform bioassays of drugs using validated bioanalytical methods to provide concentration data to determine PK parameters for parent drugs and metabolites.
Industry standards require the identification and characterization of metabolites that account for more than 10% of total measured drug and metabolite exposure (other health regulators outside the US have similar requirements). Understanding human metabolite characterization and metabolite structure identification (MetID) of drugs is critical.
Develop a comprehensive clinical pharmacology plan to prepare your development program for the next step.
As with all of our live services, we make sure to keep in touch during the study. If you have any special needs or questions about our services, please feel free to contact us to support our experienced experts. We look forward to working with you in the future.