Case Study: From Complex Radiochemistry to Clinical ADME Data

Human ADME studies remain an essential component of drug development, providing critical insight into drug absorption, distribution, metabolism and excretion. For this programme, a clinical-stage sponsor required the development of a carbon-14 radiolabelled compound and the successful execution of a human ADME study despite significant radiochemistry, manufacturing and analytical challenges.

Arcinova and Quotient Sciences delivered an integrated solution spanning radiolabelling strategy, drug substance development, GMP drug product manufacture, clinical conduct and bioanalysis. Through close collaboration and coordinated project management, the programme progressed efficiently from complex radiosynthesis to generation of the clinical metabolism data needed to support further development.

Download the case study to learn how an integrated CMC, clinical and bioanalytical approach streamlined ADME study delivery and reduced development risk.