BioPharm International - March 2021

BioPharm International - Regulatory Sourcebook - March 2021

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Page 26 of 47 March 2021 eBook BioPharm International 27 Enabling the Virtual Human Through Physiologically-based Pharmacokinetic Modeling Advances in computational sciences and better understanding of human physiology are enabling researchers to better predict drug outcomes. P redictive 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 pharmacoki- netic (PBPK) modeling and its impact in streamlining the drug development process. Over the past two decades, significant advances have been made in the areas of modeling the disposition, efficacy, and safety of drugs to streamline clinical devel- opment and increase the probability of success (1). One approach is the use of PBPK modeling (2). PBPK models are mathematical platforms that integrate system param- eters (species physiology) and drug characteristics to simulate the PK of a drug (3–5). These models have pro- gressed from simple equations to sophisticated software tools representing different body compartments, under- lying physiology and biology, multiple drug components, and interindividual variability (3). Basic PBPK models define system-dependent param- eters by volume, blood flow rate, and species-specific tissue composition (3). The simplest PBPK models assume perfusion rate limited distribution within the Paulista - Heidi J. Einolf, Stephen D. Hall, Tracy Williams, Aarti Patel, Christopher Gibson, Nancy G.B. Agrawal, and Jens Sydor; all authors are members of the IQ Consortium. Regulatory Sourcebook Quality Collaboration

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