Applied concepts in PBPK modeling: how to build a PBPK/PD model
L Kuepfer, C Niederalt, T Wendl… - CPT …, 2016 - Wiley Online Library
The aim of this tutorial is to introduce the fundamental concepts of physiologically based
pharmacokinetic/pharmacodynamic (PBPK/PD) modeling with a special focus on their …
pharmacokinetic/pharmacodynamic (PBPK/PD) modeling with a special focus on their …
PBPK models for CYP3A4 and P‐gp DDI prediction: a modeling network of rifampicin, itraconazole, clarithromycin, midazolam, alfentanil, and digoxin
N Hanke, S Frechen, D Moj, H Britz… - CPT …, 2018 - Wiley Online Library
According to current US Food and Drug Administration (FDA) and European Medicines
Agency (EMA) guidance documents, physiologically based pharmacokinetic (PBPK) …
Agency (EMA) guidance documents, physiologically based pharmacokinetic (PBPK) …
Regulatory toxicology in the twenty-first century: challenges, perspectives and possible solutions
T Tralau, M Oelgeschläger, R Gürtler… - Archives of …, 2015 - Springer
The advent of new testing systems and “omics”-technologies has left regulatory toxicology
facing one of the biggest challenges for decades. That is the question whether and how …
facing one of the biggest challenges for decades. That is the question whether and how …
A systematic evaluation of the use of physiologically based pharmacokinetic modeling for cross-species extrapolation
Transfer of knowledge along the different phases of drug development is a fundamental
process in pharmaceutical research. In particular, cross-species extrapolation between …
process in pharmaceutical research. In particular, cross-species extrapolation between …
Integrating cellular metabolism into a multiscale whole-body model
Cellular metabolism continuously processes an enormous range of external compounds into
endogenous metabolites and is as such a key element in human physiology. The …
endogenous metabolites and is as such a key element in human physiology. The …
A physiologically based pharmacokinetic model of voriconazole integrating time-dependent inhibition of CYP3A4, genetic polymorphisms of CYP2C19 and …
Background Voriconazole, a first-line antifungal drug, exhibits nonlinear pharmacokinetics
(PK), together with large interindividual variability but a narrow therapeutic range, and …
(PK), together with large interindividual variability but a narrow therapeutic range, and …
A physiologically based pharmacokinetic model for pregnant women to predict the pharmacokinetics of drugs metabolized via several enzymatic pathways
Background Physiologically based pharmacokinetic modeling is considered a valuable tool
for predicting pharmacokinetic changes in pregnancy to subsequently guide in-vivo …
for predicting pharmacokinetic changes in pregnancy to subsequently guide in-vivo …
Physiologically-based modelling in mice suggests an aggravated loss of clearance capacity after toxic liver damage
Diseases and toxins may lead to death of active liver tissue, resulting in a loss of total
clearance capacity at the whole-body level. However, it remains difficult to study, whether …
clearance capacity at the whole-body level. However, it remains difficult to study, whether …
Physiologically based pharmacokinetic modeling of monoclonal antibodies in pediatric populations using PK-Sim
Physiologically based pharmacokinetic (PBPK) models are increasingly used to support
pediatric dose selection for small molecule drugs. In contrast, only a few pediatric PBPK …
pediatric dose selection for small molecule drugs. In contrast, only a few pediatric PBPK …
Physiologically‐based pharmacokinetic modeling characterizes the CYP3A‐mediated drug‐drug interaction between fluconazole and sildenafil in infants
SN Salerno, A Edginton, JG Gerhart… - Clinical …, 2021 - Wiley Online Library
Physiologically‐based pharmacokinetic (PBPK) modeling can potentially predict pediatric
drug‐drug interactions (DDIs) when clinical DDI data are limited. In infants for whom …
drug‐drug interactions (DDIs) when clinical DDI data are limited. In infants for whom …