The success of a drug candidate to reach the market requires a rigorous investigation into its toxicological profile. Therefore, ADME (Absorption, Distribution, Metabolism and Excretion) studies must be executed at an early stage in the clinical development of the
investigational drug.
The data obtained from these metabolism studies will enable a decision on whether to proceed to more advanced costly clinical trials. In order to carry out a metabolism study it is necessary to incorporate specific isotopic label(s) into the investigational drug.
