Physiologically based pharmacokinetic (PBPK) modeling and simulation approaches: a systematic review of published models, applications, and model verification

JE Sager, J Yu, I Ragueneau-Majlessi… - Drug Metabolism and …, 2015 - ASPET
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 …

Assessing the bioaccumulation potential of ionizable organic compounds: Current knowledge and research priorities

JM Armitage, RJ Erickson… - Environmental …, 2017 - Wiley Online Library
The objective of the present study was to review the current knowledge regarding the
bioaccumulation potential of ionizable organic compounds (IOCs), with a focus on the …

Translating dosages from animal models to human clinical trials—revisiting body surface area scaling

OL Blanchard, JM Smoliga - The faseb journal, 2015 - Wiley Online Library
Body surface area (BSA) scaling has been used for prescribing individualized dosages of
various drugs and has also been recommended by the US Food and Drug Administration as …

Prediction of human pharmacokinetics using physiologically based modeling: a retrospective analysis of 26 clinically tested drugs

SS De Buck, VK Sinha, LA Fenu, MJ Nijsen… - Drug Metabolism and …, 2007 - ASPET
The aim of this study was to evaluate different physiologically based modeling strategies for
the prediction of human pharmacokinetics. Plasma profiles after intravenous and oral dosing …

PBPK modelling of inter-individual variability in the pharmacokinetics of environmental chemicals

FY Bois, M Jamei, HJ Clewell - Toxicology, 2010 - Elsevier
Generic PBPK models, applicable to a large number of substances, coupled to parameter
databases and QSAR modules, are now available for predictive modelling of inter-individual …

Whole-body physiologically based pharmacokinetic models

I Nestorov - Expert opinion on drug metabolism & toxicology, 2007 - Taylor & Francis
This review summarizes the most recent developments in and applications of physiologically
based pharmacokinetic (PBPK) modeling methodology originating from both the …

Physiologically based pharmacokinetic modeling: methodology, applications, and limitations with a focus on its role in pediatric drug development

F Khalil, S Läer - BioMed Research International, 2011 - Wiley Online Library
The concept of physiologically based pharmacokinetic (PBPK) modeling was introduced
years ago, but it has not been practiced significantly. However, interest in and …

Towards prediction of in vivo intestinal absorption using a 96-well Caco-2 assay

S Skolnik, X Lin, J Wang, XH Chen, T He… - Journal of pharmaceutical …, 2010 - Elsevier
We systematically validated a robust 96-well Caco-2 assay via an extended set of 93
marketed drugs with diverse transport mechanisms and quantified by LC/MS/MS, to …

[HTML][HTML] Metabolic Profiling of Human Long-Term Liver Models and Hepatic Clearance Predictions from In Vitro Data Using Nonlinear Mixed-Effects Modeling

NA Kratochwil, C Meille, S Fowler, F Klammers… - The AAPS journal, 2017 - Springer
Early prediction of human clearance is often challenging, in particular for the growing
number of low-clearance compounds. Long-term in vitro models have been developed …

Physiologically based pharmacokinetics (PBPK)

P Espié, D Tytgat, ML Sargentini-Maier… - Drug metabolism …, 2009 - Taylor & Francis
Allometric scaling is widely used to predict human pharmacokinetic parameters from
preclinical species, and many different approaches have been proposed over the years to …