Application of physiologically based pharmacokinetic modeling of novel drugs approved by the U.S. food and drug administration

The article from the European Journal of Pharmaceutical Sciences reviews the role of Physiologically Based Pharmacokinetic (PBPK) modeling in the FDA’s approval of novel drugs from 2019 to 2023. It highlights that PBPK models are crucial for predicting drug pharmacokinetics using preclinical data, enhancing drug development efficiency. Out of 243 approved drugs, 74 utilized PBPK models, primarily for assessing drug-drug interactions (74.2% of applications). The use of software platforms, especially Simcyp, has streamlined this process. Despite existing challenges, the growing success of PBPK applications indicates its potential in drug development, making it a standard part of the FDA approval process and providing valuable insights for researchers.