PBPK models for the prediction of in vivo performance of oral dosage forms

ES Kostewicz, L Aarons, M Bergstrand… - European Journal of …, 2014 - Elsevier
Drug absorption from the gastrointestinal (GI) tract is a highly complex process dependent
upon numerous factors including the physicochemical properties of the drug, characteristics …

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 …

Regulation of drug transport proteins—From mechanisms to clinical impact: A white paper on behalf of the international transporter consortium

KLR Brouwer, R Evers, E Hayden, S Hu… - Clinical …, 2022 - Wiley Online Library
Membrane transport proteins are involved in the absorption, disposition, efficacy, and/or
toxicity of many drugs. Numerous mechanisms (eg, nuclear receptors, epigenetic gene …

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) …

Physiologically‐based pharmacokinetic models for evaluating membrane transporter mediated drug–drug interactions: current capabilities, case studies, future …

KS Taskar, V Pilla Reddy, H Burt… - Clinical …, 2020 - Wiley Online Library
Physiologically‐based pharmacokinetic (PBPK) modeling has been extensively used to
quantitatively translate in vitro data and evaluate temporal effects from drug–drug …

The impact of food intake on the luminal environment and performance of oral drug products with a view to in vitro and in silico simulations: a PEARRL review

C Pentafragka, M Symillides… - Journal of Pharmacy …, 2019 - academic.oup.com
Objectives Using the type of meal and dosing conditions suggested by regulatory agencies
as a basis, this review has two specific objectives: first, to summarize our understanding on …

Intestinal P‐gp and putative hepatic OATP1B induction: international transporter consortium perspective on drug development implications

MJ Zamek‐Gliszczynski, M Patel… - Clinical …, 2021 - Wiley Online Library
There is an increasing interest in transporter induction (ie, decreased systemic drug
exposure due to increased efflux‐limited absorption or transporter‐mediated clearance) as a …

Prediction of drug–drug interaction potential using physiologically based pharmacokinetic modeling

JS Min, SK Bae - Archives of pharmacal research, 2017 - Springer
The occurrence of drug–drug interactions (DDIs) can significantly affect the safety of a
patient, and thus assessing DDI risk is important. Recently, physiologically based …

Physiologically‐based pharmacokinetic modeling approach to predict rifampin‐mediated intestinal P‐glycoprotein induction

S Yamazaki, C Costales, S Lazzaro… - CPT …, 2019 - Wiley Online Library
Physiologically‐based pharmacokinetic (PBPK) modeling is a powerful tool to quantitatively
describe drug disposition profiles in vivo, thereby providing an alternative to predict drug …

Drug absorption related nephrotoxicity assessment on an intestine-kidney chip

Z Li, W Su, Y Zhu, T Tao, D Li, X Peng, J Qin - Biomicrofluidics, 2017 - pubs.aip.org
Drug absorption in the intestine is tightly related to drug-induced nephrotoxicity, which is a
relatively common side effect in clinical practice. It highlights a great need to develop …