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Summary of Population Pharmacokinetics

Population pharmacokinetics (popPK) is that the study of variability in drug concentrations within a patient population receiving clinically relevant doses of a drug of interest. PopPK methods use mathematical models to explain PK data and draw conclusions. PopPK models can help guide decision-making across all phases of drug development and may also provide critical support for efficacy and safety in marketing applications like new drug applications (NDAs) and biologics license applications (BLAs).

Not surprisingly, regulatory emphasis on popPK modeling continues to extend. Former FDA Commissioner, Dr. Scott Gottlieb, noted that just about 100% of all NDAs for brand new molecular entities (NMEs) include aspects of modeling and simulation. over ever, both regulators and drug developers are realizing the ability and utility of popPK modeling. So, let’s take a deeper take a look at what we mean by “population pharmacokinetics.”