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Basic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
Predictive sciences—built on improved computational capabilities and a deeper understanding of human physiology—are allowing researchers to perform human studies prior to, and sometimes in place of, human clinical trials in order to predict drug outcomes. Representatives of the Translational & ADME Sciences Leadership Group (TALG) in the IQ Consortium review the basic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process.
eBook: Regulatory Sourcebook
When referring to this article, please cite it as H. Einolf, et al., " Enabling the Virtual Human Through Physiologically-based Pharmacokinetic Modeling," BioPharm International Regulatory Sourcebook eBook (March 2021).