3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory consideration

H Wang, PC Brown, ECY Chow, L Ewart… - Clinical and …, 2021 - Wiley Online Library
Nonclinical testing has served as a foundation for evaluating potential risks and
effectiveness of investigational new drugs in humans. However, the current two‐dimensional …

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 …

Predicting clearance mechanism in drug discovery: extended clearance classification system (ECCS)

MV Varma, SJ Steyn, C Allerton, AF El-Kattan - Pharmaceutical research, 2015 - Springer
Early prediction of clearance mechanisms allows for the rapid progression of drug discovery
and development programs, and facilitates risk assessment of the pharmacokinetic …

[HTML][HTML] Metformin and cimetidine: Physiologically based pharmacokinetic modelling to investigate transporter mediated drug–drug interactions

HJ Burt, S Neuhoff, L Almond, L Gaohua… - European journal of …, 2016 - Elsevier
Metformin is used as a probe for OCT2 mediated transport when investigating possible DDIs
with new chemical entities. The aim of the current study was to investigate the ability of …

Evaluation of pharmacokinetic drug–drug interactions: a review of the mechanisms, in vitro and in silico approaches

Y Peng, Z Cheng, F Xie - Metabolites, 2021 - mdpi.com
Pharmacokinetic drug–drug interactions (DDIs) occur when a drug alters the absorption,
transport, distribution, metabolism or excretion of a co-administered agent. The occurrence …

Comparing various in vitro prediction criteria to assess the potential of a new molecular entity to inhibit organic anion transporting polypeptide 1B1

J Vaidyanathan, K Yoshida, V Arya… - The Journal of Clinical …, 2016 - Wiley Online Library
Abstract Evaluation of organic anion transporting polypeptide (OATP) 1B1–mediated drug‐
drug interactions (DDIs) is an integral part of drug development and is recommended by …

Biomarker‐informed model‐based risk assessment of organic anion transporting polypeptide 1B mediated drug‐drug interactions

E Kimoto, C Costales, MA West, Y Bi… - Clinical …, 2022 - Wiley Online Library
Quantitative prediction of drug‐drug interactions (DDIs) involving organic anion transporting
polypeptide (OATP) 1B1/1B3 inhibition is limited by uncertainty in the translatability of …

Quantitative analyses of hepatic OATP‐mediated interactions between statins and inhibitors using PBPK modeling with a parameter optimization method

T Yoshikado, K Yoshida, N Kotani… - Clinical …, 2016 - Wiley Online Library
This study aimed to construct a widely applicable method for quantitative analyses of drug–
drug interactions (DDIs) caused by the inhibition of hepatic organic anion transporting …

Quantitative contribution of six major transporters to the hepatic uptake of drugs:“SLC-phenotyping” using primary human hepatocytes

Y Bi, C Costales, S Mathialagan, M West… - … of Pharmacology and …, 2019 - ASPET
Hepatic uptake transporters [solute carriers (SLCs)], including organic anion transporting
polypeptide (OATP) 1B1, OATP1B3, OATP2B1, sodium-dependent taurocholate …

Reimagining the framework supporting the static analysis of transporter drug interaction risk; integrated use of biomarkers to generate pan‐transporter inhibition …

AD Rodrigues - Clinical Pharmacology & Therapeutics, 2023 - Wiley Online Library
Solute carrier (SLC) transporters present as the loci of important drug–drug interactions
(DDIs). Therefore, sponsors generate in vitro half‐maximal inhibitory concentration (IC50) …