Impact of physiologically based pharmacokinetic models on regulatory reviews and product labels: Frequent utilization in the field of oncology

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A physiologically based pharmacokinetic (PBPK) model is a mathematical model that simulates pharmacokinetics of xenobiotics in the human or animal body by reflecting the current physiological understanding related to absorption, distribution, metabolism, and elimination. One salient feature is that PBPK models allow for the mechanistic and prospective prediction of a drug's pharmacokinetic profiles and aids in new drug development and regulatory decision‐making process.1 We surveyed the utilization of PBPK in the US Food and Drug Administration (FDA) approval, specifically focusing on their application and impact on labeling recommendations.
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