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Heidi J. Einolf is director, modeling and simulation, pharmacokinetic sciences, Novartis.
Stephen D. Hall is senior research fellow, drug disposition, Eli Lilly and Co.
Tracy Williams is senior director ADME/Toxicology/PKPD, Eli Lilly and Co.
Aarti Patel is director, DMPK modeling, GlaxoSmithKline.
Christopher Gibson is distinguished scientist, Merck.
Nancy G.B. Agrawal is vice-president, pharmacokinetics, pharmacodynamics, and drug metabolism, Merck.
Jens Sydor is vice-president, DMPK, GlaxoSmithKline.
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).