Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A Systematic Review of Published Models, Applications, and Model Verification

• Published in: Drug metabolism and disposition Vol. 43; no. 11; pp. 1823 - 1837
• Main Authors: Sager, Jennifer E., Yu, Jingjing, Ragueneau-Majlessi, Isabelle, Isoherranen, Nina
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01.11.2015; The American Society for Pharmacology and Experimental Therapeutics
• Subjects: Animals; Computer Simulation; Drug Interactions - physiology; Humans; Minireview; Models, Biological; Pharmaceutical Preparations - metabolism; Pharmacokinetics; CDER; FDA; PD; CHMP; IVIVE; DDI; EMA; IQ; PBPK; PK; AUC

Modeling and simulation of drug disposition has emerged as an important tool in drug development, clinical study design and regulatory review, and the number of physiologically based pharmacokinetic (PBPK) modeling related publications and regulatory submissions have risen dramatically in recent yea...