[PDF][PDF] Extended Clearance Classification System (ECCS) informed approach for evaluating investigational drugs as substrates of drug transporters

MV Varma, AF El‐Kattan, B Feng… - Clinical …, 2017 - researchgate.net
Drug transporters are recognized widely for their role in clinical pharmacokinetics and drug–
drug interactions (DDIs). This has provided impetus to the inclusion of transporter substrate …

[引用][C] Biomarkers Come of Age in Clinical Pharmacology

KM Giacomini - Clinical Pharmacology & Therapeutics, 2023 - Wiley Online Library
Therapeutics in 2001, the National Institutes of Health Biomarkers Definitions Working
Group provided an early definition of a biomarker as “a characteristic that is objectively …

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 …

Theoretical considerations on quantitative prediction of drug-drug interactions

A Hisaka, Y Ohno, T Yamamoto, H Suzuki - Drug metabolism and …, 2010 - Elsevier
The prediction of drug-drug interactions (DDIs) associated with change in clearance for
metabolism is reviewed, particularly focusing on pharmacokinetic theories for prediction …

Drug–drug interactions related to altered absorption and plasma protein binding: Theoretical and regulatory considerations, and an industry perspective

J Hochman, C Tang, T Prueksaritanont - Journal of pharmaceutical …, 2015 - Elsevier
Drug–drug interactions (DDIs) related to altered drug absorption and plasma protein binding
have received much less attention from regulatory agencies relative to DDIs mediated via …

Transporter‐Mediated Drug–Drug Interactions Involving OATP Substrates: Predictions Based on In Vitro Inhibition Studies

K Yoshida, K Maeda… - Clinical Pharmacology & …, 2012 - Wiley Online Library
Transporter‐mediated drug–drug interactions (DDIs) are among the most important of the
clinically relevant pharmacokinetic DDIs. We investigated the validity of a static prediction of …

Evaluation of transporters in drug development: current status and contemporary issues

SC Lee, V Arya, X Yang, DA Volpe, L Zhang - Advanced Drug Delivery …, 2017 - Elsevier
Transporters govern the access of molecules to cells or their exit from cells, thereby
controlling the overall distribution of drugs to their intracellular site of action. Clinically …

Progress in the Quantitative Assessment of Transporter-Mediated Drug–Drug Interactions Using Endogenous Substrates in Clinical Studies

T Mochizuki, H Kusuhara - Drug Metabolism and Disposition, 2023 - ASPET
Variations in drug transporter activities, caused by genetic polymorphism and drug–drug
interactions (DDIs), alter the systemic exposure of substrate drugs, leading to differences in …

Scientific perspectives on drug transporters and their role in drug interactions

L Zhang, JM Strong, W Qiu, LJ Lesko… - Molecular …, 2006 - ACS Publications
Recently, increased interest in drug transporters and research in this area has revealed that
drug transporters play an important role in modulating drug absorption, distribution, and …

Use of clearance concepts and modeling techniques in the prediction of metabolic drug–drug interactions

K Ito, Y Sugiyama - Trends in pharmacological sciences, 2010 - cell.com
Quantitative prediction of the in vivo drug–drug interactions (DDIs) caused by metabolic
inhibition, one of the most common DDI mechanisms in clinical practice, has long been …