2019 PharmSci 360
Drug metabolism and drug-drug interaction (DDI) studies often take a back seat to toxicity studies when preparing for an IND. Cross-species metabolite identification and plasma protein binding are typically considered sufficient for an IND. Metabolism studies can help bridge in vivo data to clinical outcomes. Furthermore, recent guidance documents from regulatory bodies indicate that DDI studies should be done before clinical studies. Lastly, when is appropriate time to conduct an ADME study in a pre-clinical species?