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. 

Learn about Synthesis-to-Clinic®

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. 

Our Nottingham, UK clinical site includes a dedicated ADME ward that is fully integrated with our dedicated pharmaceutical sciences facilities for the development, real time Good Manufacturing Practice (GMP) manufacture, and qualified person (QP) release of 14C labeled drug products. Coupled with our excellent volunteer recruitment, retention, and completion record, this has enabled us to conduct studies with a 100% success rate. 

We are also able to develop, manufacture, and release GMP drug products at our Alnwick, UK, facility, which has the capability to produce radiolabeled 14C drug substances for both clinical and non-clinical studies. 

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. 

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