Quality assurance of PBPK modeling platforms and guidance on building, evaluating, verifying and applying PBPK models prudently under the umbrella of …

S Frechen, A Rostami-Hodjegan - Pharmaceutical research, 2022 - Springer
Modeling and simulation emerges as a fundamental asset of drug development. Mechanistic
modeling builds upon its strength to integrate various data to represent a detailed structural …

The role of “physiologically based pharmacokinetic model (PBPK)” new approach methodology (NAM) in pharmaceuticals and environmental chemical risk …

D Deepika, V Kumar - … Journal of Environmental Research and Public …, 2023 - mdpi.com
Physiologically Based Pharmacokinetic (PBPK) models are mechanistic tools generally
employed in the pharmaceutical industry and environmental health risk assessment. These …

Data digitizing: accurate and precise data extraction for quantitative systems pharmacology and physiologically‐based pharmacokinetic modeling

JG Wojtyniak, H Britz, D Selzer… - CPT …, 2020 - Wiley Online Library
In quantitative systems pharmacology (QSP) and physiologically‐based pharmacokinetic
(PBPK) modeling, data digitizing is a valuable tool to extract numerical information from …

Complete populations of virtual patients for in silico clinical trials

S Sinisi, V Alimguzhin, T Mancini, E Tronci… - …, 2020 - academic.oup.com
Motivation Model-based approaches to safety and efficacy assessment of pharmacological
drugs, treatment strategies or medical devices (In Silico Clinical Trial, ISCT) aim to decrease …

Studying metabolism with multi-organ chips: new tools for disease modelling, pharmacokinetics and pharmacodynamics

T Shroff, K Aina, C Maass, M Cipriano… - Open …, 2022 - royalsocietypublishing.org
Non-clinical models to study metabolism including animal models and cell assays are often
limited in terms of species translatability and predictability of human biology. This field …

Physiologically based precision dosing approach for drug‐drug‐gene interactions: a simvastatin network analysis

JG Wojtyniak, D Selzer, M Schwab… - Clinical Pharmacology & …, 2021 - Wiley Online Library
Drug‐drug interactions (DDIs) and drug‐gene interactions (DGIs) are well known mediators
for adverse drug reactions (ADRs), which are among the leading causes of death in many …

[HTML][HTML] Physiologically based pharmacokinetic (PBPK) modelling of oral drug absorption in older adults–an AGePOP review

C Demeester, D Robins, AE Edwina, J Tournoy… - European Journal of …, 2023 - Elsevier
The older population consisting of persons aged 65 years or older is the fastest-growing
population group and also the major consumer of pharmaceutical products. Due to the …

A physiologically based pharmacokinetic model of ketoconazole and its metabolites as drug–drug interaction perpetrators

FZ Marok, JG Wojtyniak, LM Fuhr, D Selzer, M Schwab… - Pharmaceutics, 2023 - mdpi.com
The antifungal ketoconazole, which is mainly used for dermal infections and treatment of
Cushing's syndrome, is prone to drug–food interactions (DFIs) and is well known for its …

[HTML][HTML] Physiologically based pharmacokinetic modeling of brivaracetam and its interactions with rifampin based on CYP2C19 phenotypes

H Yang, L Yang, X Zhong, X Jiang, L Zheng… - European Journal of …, 2022 - Elsevier
Abstract Brivaracetam (BRV), a third-generation antiepileptic drug (AED), is primarily
metabolized through amidase hydrolysis and CYP2C19-mediated hydroxylation in vivo. This …

A comprehensive whole-body physiologically based pharmacokinetic drug–drug–gene interaction model of metformin and cimetidine in healthy adults and renally …

N Hanke, D Türk, D Selzer, N Ishiguro, T Ebner… - Clinical …, 2020 - Springer
Background Metformin is a widely prescribed antidiabetic BCS Class III drug (low
permeability) that depends on active transport for its absorption and disposition. It is …