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Recent\n                    <jats:italic>in vitro<\/jats:italic>\n                    studies indicate that the\n                    <jats:italic>K<\/jats:italic>\n                    <jats:sub>\n                      <jats:italic>i<\/jats:italic>\n                    <\/jats:sub>\n                    values for OCT2 exhibit substrate dependency and increase in potency with pre\u2010incubation. However, consensus is lacking on whether these factors should be considered in predicting\n                    <jats:italic>in vivo<\/jats:italic>\n                    inhibition. Physiologically based pharmacokinetic models, combined with the extended clearance concept, have been used and are discussed here for OCT2\/MATEs probes. In addition to modeling, early clinical studies use endogenous biomarkers to evaluate transporter\u2010mediated DDI risk, with the aim of avoiding unnecessary clinical DDI studies. Identified biomarkers for OCT2\/MATEs, such as creatinine, N\n                    <jats:sup>1<\/jats:sup>\n                    \u2010methylnicotinamide, and N\n                    <jats:sup>1<\/jats:sup>\n                    \u2010methyladenosine, have proven useful in confirming clinically relevant OCT2\/MATEs\u2010mediated DDIs when renal clearance (CLr) is used as an endpoint; their application is discussed further. From a clinical perspective, the intact nephron hypothesis (INH), which postulates that the decrease in CLr in chronic kidney disease (CKD) is proportional to that in nephron numbers, has been proposed. However, reports suggest that the secretion clearance of creatinine and substrates of organic anion transporters (OATs) does not follow this proportionality in patients with CKD. This state\u2010of\u2010the\u2010art review highlights key developments in predicting OCT2\/MATEs\u2010mediated DDIs in healthy volunteers and explores the prediction of clinical OCT2\/MATEs DDI risk in patients with CKD by comparing substrate\u2010dependent changes in secretion clearance for substrates of OCT2\/MATEs and OATs. Recommendations for the prediction of OCT2\/MATEs\u2010mediated DDI risk, together with the current knowledge gaps and future directions, are discussed.\n                  <\/jats:p>","DOI":"10.1002\/cpt.3727","type":"journal-article","created":{"date-parts":[[2025,5,27]],"date-time":"2025-05-27T11:40:21Z","timestamp":1748346021000},"page":"994-1014","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Predicting\n                    <scp>OCT2<\/scp>\n                    \/\n                    <scp>MATEs<\/scp>\n                    \u2010Mediated Drug Interactions in Healthy Volunteers and Patients with Chronic Kidney Disease: Insights from Extended Clearance Concept, Endogenous Biomarkers, and\n                    <i>In Vitro<\/i>\n                    Inhibition Studies (Perspectives from the International Transporter Consortium)"],"prefix":"10.1002","volume":"118","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8489-2960","authenticated-orcid":false,"given":"Satoshi","family":"Asano","sequence":"first","affiliation":[{"name":"Translational Research Division Chugai Pharmaceutical Co., Ltd.  Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3933-5217","authenticated-orcid":false,"given":"Aleksandra","family":"Galetin","sequence":"additional","affiliation":[{"name":"Centre for Applied Pharmacokinetic Research, University of Manchester  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5422-792X","authenticated-orcid":false,"given":"Yoshiko","family":"Tomita","sequence":"additional","affiliation":[{"name":"Clinical Research, Drug Development Division Sumitomo Pharma Co., Ltd.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8041-5430","authenticated-orcid":false,"given":"Kathleen M.","family":"Giacomini","sequence":"additional","affiliation":[{"name":"Department of Bioengineering and Therapeutic Sciences University of California San Francisco  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7223-9000","authenticated-orcid":false,"given":"Xiaoyan","family":"Chu","sequence":"additional","affiliation":[{"name":"Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB), Merck &amp; Co., Inc.  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8689-8231","authenticated-orcid":false,"given":"Xinning","family":"Yang","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2766-7203","authenticated-orcid":false,"given":"Toshimichi","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Non\u2010Clinical Biomedical Science, Applied Research &amp; Operations Astellas Pharma Inc.  Ibaraki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Kusuhara","sequence":"additional","affiliation":[{"name":"Laboratory of Molecular Pharmacokinetics Graduate School of Pharmaceutical Sciences, The University of Tokyo  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8452-8835","authenticated-orcid":false,"given":"Yuichi","family":"Sugiyama","sequence":"additional","affiliation":[{"name":"Laboratory of Quantitative System Pharmacokinetics\/Pharmacodynamics Innovation Base, Josai International University  Tokyo Japan"},{"name":"iHuman Institute, ShanghaiTech University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,5,27]]},"reference":[{"key":"e_1_2_15_1_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01062963"},{"key":"e_1_2_15_2_1","first-page":"11","article-title":"Structure and function of renal organic cation transporters","volume":"13","author":"Koepsell H.","year":"1998","journal-title":"News Physiol. 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