Radiolabeled In Vivo ADME Studies Context

Radiolabeled studies also known as ADME studies are required by regulatory authorities for the registration of a new drug and, therefore, are an integral part of the majority of drug development programs. Excretion studies are usually conducted in at least two preclinical species which are used for long-term safety assessment of the drug and in most cases in humans as well. These studies not only determine the rates and routes of excretion, but also provide very critical information on the metabolic pathways of drugs in preclinical species and humans.
Quantitative whole-body autoradiography (QWBA) studies in preclinical species must be performed to ensure drug safety and to calculate the maximum radioactive dose that can be administered to humans. QWBA studies also provide information on the distribution, accumulation, and retention of drug material.

Discover more about our in-vivo ADME services:

• Radiolabeled Pharmacokinetics
• Excretion Balance in rodents
• Excretion Balance in non-rodents
• Whole Body Autoradiography (QWBA)