Role of physiologically-based pharmacokinetics in regulatory submissions
AbstractPhysiologically based pharmacokinetic (PBPK) is an approach that help predict the absorption, distribution, metabolism and excretion (ADME) properties of candidate drugs in animal/human and evaluate the effects of intrinsic (e.g. organ dysfunction, age, genetics) and extrinsic (e.g. diet, smoking habit, drug-drug interactions) factors, alone or in combinations, on drug exposure, during drug discovery and development […]