Meeting the demands of regulatory requirements: the significance of ADME

“ADME will continue to play an active and expanding role in drug discovery and development, particularly in helping improve the accuracy and precision of PK/PD model predictions...” When I began my career in the mid-1980s as a pharmacokineticist in the pharmaceutical industry, we scientists dedicated to the study of absorption, distribution, metabolism and excretion (ADME) were relegated mostly to a characterization role – defining bioavailability, protein binding, metabolic pathways, and so on, for new molecular entities (NMEs) in development. Drug discovery was oriented toward identifying lead candidates with the highest target activity, irrespective of their physicochemical or pharmacokinetic (PK) properties....