Light Label ADME studies
Light label ADME studies use accelerator mass spectrometry to enable the generation of metabolism data early in a clinical programme through the administration of a light label 14C IMP. The light label clinical approach involves the administration of a small amount of 14C IMP along with a ‘therapeutic’ cold dose of the IMP. This type of study can be performed at an early stage in the clinical development programme and typically will not require dosimetry information in advance of the study. Such a study can provide an insight into potential metabolism problems early in clinical development which will inform the design of phase II studies, the regulatory ADME study and may influence the selection of species for the longer term toxicology studies. Such data can enable projects to be fixed or de-prioritised before incurring substantial costs and delays in later stage development.
For more details on our human ADME capabilities please refer to our Factsheet.
IMP - investigational medicinal product