Synthesis-to-Clinic®: A streamlined approach to 14C human ADME studies

We are a leading provider of 14C-enabled drug development programs, successfully conducting over 350 human ADME radiolabeled programs to date. 

The Quotient Sciences Synthesis-to-Clinic® approach seamlessly delivers human ADME studies, from radiosynthesis of the 14C-labeled drug substance through all the required steps of the human study and the final clinical report, in an integrated program of work. 

Whether conducting human ADME for New Drug Applications (NDA) or running in parallel with Phase II Proof of Concept (POC) studies, our Synthesis-to-Clinic® integrated ADME studies are enabled by applying Translational Pharmaceutics®. Our Nottingham, UK clinical site includes a dedicated ADME ward that is fully integrated with our dedicated pharmaceutical sciences facilities for the development, GMP manufacture, and QP release of 14C labeled drug products. In addition, our excellent volunteer recruitment, retention, and completion record has enabled us to conduct studies with a 100% success rate. 

As well as conventional human ADME studies, where the radiolabeled dose is selected following appropriate dosimetry assessment, Quotient Sciences are experts in microADME studies, where the radiolabeled dose is no more than 1 microcurie (µCi) and no dosimetry studies are required to support the radiolabeled dose selection. 

Learn more about Synthesis-to-Clinic®, a novel approach to integrated ADME studies

Download our whitepaper to continue reading about the benefits of the Quotient Sciences Synthesis-to-Clinic® approach to conducting human ADME programs.