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One common pharmacokinetic (PK) characteristic of these four DOACs is that renal excretion contributes 27% or more in their elimination, resulting in age\u2010dependent drug clearance in both pediatric and adult subjects. Several lessons have been learned from adult exposure matching and pediatric dose selection for DOACs. The main goal of this tutorial is to provide an informed perspective on pediatric dose selection for renally excreted drugs, using these four DOACs as case examples. This tutorial is organized into seven steps: (1) consideration of age\u2010related differences in disease and response to treatment; (2) consideration of age\u2010related differences in drug absorption, distribution, metabolism, and excretion; (3) selection of the reference adult population and exposure for pediatric exposure matching; (4) prediction of pediatric clearance and pediatric dose selection based on data from young adults; (5) conduct and design of efficient pediatric PK and pharmacodynamic (PD) studies that inform dose selection; (6) assessment of exposure matching and dose adjustment using population PK simulation; (7) evaluation of the need for dose adjustment in pediatric sub\u2010populations.<\/jats:p>","DOI":"10.1002\/cpt.3396","type":"journal-article","created":{"date-parts":[[2024,8,13]],"date-time":"2024-08-13T12:29:58Z","timestamp":1723552198000},"page":"1174-1187","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Exposure Matching\u2010Based Pediatric Dose Selection for Drugs with Renal Excretion \u2013 Lessons Learned from Pediatric Development of Direct Oral Anticoagulants"],"prefix":"10.1002","volume":"116","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0416-2731","authenticated-orcid":false,"given":"Peng","family":"Zou","sequence":"first","affiliation":[{"name":"Quantitative Clinical Pharmacology Daiichi Sankyo Inc.  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