www.biopharminternational.com 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
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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
