ABSTRACT
Drug development is a long and expensive process. Unfortunately, around 75% of drug development cost is associated with drug candidates that failed in the early stages of development and did not make it to the market [1,2]. One reason for the high failure rate in drug development is the unreliable prediction of absorption, distribution, metabolism, and excretion (ADME) in humans based on data generated in preclinical species. Up to 40% of new drugs under development are dropped during Phase I even though promising ADME data were obtained in animals [2]. Current methods of investigating drug metabolism and pharmacokinetics (PK) rely on animal,
in vitro, and in silico models. There is always a concern that human metabolism pathways and PK might differ signi cantly from those predicted from the animal models. Thus, there is a critical need to con rm metabolism and PK parameters in humans as early as possible, prior to large investment in clinical trials.
