{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T14:13:58Z","timestamp":1779200038488,"version":"3.51.4"},"reference-count":57,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:p>\n                    Model\u2010informed drug development is increasingly integrated across the drug development continuum, enabling more efficient, cost\u2010effective, and targeted trials while reducing reliance on animal studies. Achieving pharmacoequity requires not only equitable access to medicines but also to the data and knowledge that inform drug development and regulatory decisions. To address challenges in pharmacokinetic data sharing, PKRxiv (\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/pkrxiv.org\/\">https:\/\/pkrxiv.org\/<\/jats:ext-link>\n                    ) was developed as a discipline\u2010specific repository designed around Findable, Accessible, Interoperable, Reusable (FAIR) principles. This tutorial introduces PKRxiv\u2019s rationale, design, data submission and access workflows, and practical use cases. Available datasets at the end of September 2025 include over 5,500 individual drug concentration\u2010time data points from over 900 unique participants across 3 continents. The platform supports structured submission of pharmacokinetic, pharmacogenetic, and safety\/efficacy data, with persistent digital object identifiers for discoverability and citation. Contributors can apply one of three data sharing models\u2014unrestricted, noncommercial, or contributor\u2010controlled\u2014with optional embargo periods. Users can explore datasets using the Data Explorer or Data Cards, or submit requests after providing a statement of intended use case. It enables pooling of datasets across multiple studies. Recommendations to help advance the field are proposed as data sharing becomes more widely expected: obtaining consent for unspecified future research use of data, sharing data underlying peer\u2010reviewed publications as standard practice, including discipline\u2010specific repositories in data management plans, and incentivizing post\u2010approval data sharing by industry. Supporting data from all therapeutic areas and population groups, PKRxiv is a critical step toward a more transparent, equitable, and collaborative future in clinical pharmacology research.\n                  <\/jats:p>","DOI":"10.1002\/cpt.70206","type":"journal-article","created":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T11:45:18Z","timestamp":1769946318000},"page":"1235-1248","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["PKRxiv: A Best Practice Model for Advancing Pharmacoequity Through Open Pharmacokinetic Data Sharing"],"prefix":"10.1002","volume":"119","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1393-3753","authenticated-orcid":false,"given":"Shakir","family":"Atoyebi","sequence":"first","affiliation":[{"name":"Department of Biochemistry, Cell and Systems Biology, Institute of Systems, Molecular and Integrative Biology University of Liverpool  Liverpool UK"},{"name":"Centre of Excellence for Long\u2010acting Therapeutics University of Liverpool  Liverpool UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-6867-9413","authenticated-orcid":false,"given":"Prajith","family":"Venkatasubramanian","sequence":"additional","affiliation":[{"name":"Department of Biochemistry, Cell and Systems Biology, Institute of Systems, Molecular and Integrative Biology University of Liverpool  Liverpool UK"},{"name":"Centre of Excellence for Long\u2010acting Therapeutics University of Liverpool  Liverpool UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8225-145X","authenticated-orcid":false,"given":"Abdulafeez","family":"Akinloye","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry Faculty of Pharmacy, Obafemi Awolowo University  Ile Ife Nigeria"},{"name":"UniSA Clinical and Health Sciences, Health and Biomedical Innovation University of South Australia  Adelaide South Australia Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8902-4150","authenticated-orcid":false,"given":"Oluwasegun","family":"Eniayewu","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry Faculty of Pharmacy, Obafemi Awolowo University  Ile Ife Nigeria"},{"name":"Department of Pharmaceutical and Medicinal Chemistry Faculty of Pharmaceutical Sciences, University of Ilorin  Ilorin Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8569-2293","authenticated-orcid":false,"given":"Brookie M.","family":"Best","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice and Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences University of California San Diego  La Jolla California USA"},{"name":"Department of Pediatrics, School of Medicine University of California San Diego  La Jolla California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-0078-3294","authenticated-orcid":false,"given":"Laura","family":"Else","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology University of Liverpool  Liverpool UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6588-5749","authenticated-orcid":false,"given":"Adeniyi","family":"Olagunju","sequence":"additional","affiliation":[{"name":"Department of Biochemistry, Cell and Systems Biology, Institute of Systems, Molecular and Integrative Biology University of Liverpool  Liverpool UK"},{"name":"Centre of Excellence for Long\u2010acting Therapeutics University of Liverpool  Liverpool UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,2,1]]},"reference":[{"key":"e_1_2_13_1_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.17764"},{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.13002"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.2001682117"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc24-1483"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.18058"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.6184"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.13291"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2274"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.3345\/cep.2023.00535"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.7238"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15832"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-022-03288-w"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.13227"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-022-03327-6"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3006"},{"key":"e_1_2_13_16_1","unstructured":"EMA.ICH M15 Guideline on General Principles for Model\u2010Informed Drug Development<https:\/\/www.ema.europa.eu\/en\/ich\u2010m15\u2010guideline\u2010general\u2010principles\u2010model\u2010informed\u2010drug\u2010development\u2010step\u20102b\u2010scientific\u2010guideline> (2025). Accessed October 10 2025."},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3636"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10928-025-09995-2"},{"key":"e_1_2_13_19_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2022.1086551"},{"key":"e_1_2_13_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2017.06.035"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1460-9592.2009.03051.x"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10928-023-09878-4"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1155\/2023\/3081422"},{"key":"e_1_2_13_24_1","unstructured":"Nadaf R.Using pharmacokinetics to optimize dosing regimens in chronic disease management. 15 (2024)."},{"key":"e_1_2_13_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12134"},{"key":"e_1_2_13_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12870"},{"key":"e_1_2_13_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-019-00790-0"},{"key":"e_1_2_13_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12511"},{"key":"e_1_2_13_29_1","unstructured":"Kelly FitzGerald P.Obtaining informed consent for future reuse of patient data. 32 (2023)."},{"key":"e_1_2_13_30_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pdig.0000635"},{"key":"e_1_2_13_31_1","doi-asserted-by":"publisher","DOI":"10.1162\/dint_r_00024"},{"key":"e_1_2_13_32_1","doi-asserted-by":"publisher","DOI":"10.1038\/sdata.2016.18"},{"key":"e_1_2_13_33_1","unstructured":"European Commission Directorate\u2010General for Research and Innovation.Horizon Europe open science\u2014early knowledge and data sharing and open collaboration(2021)https:\/\/doi.org\/10.2777\/18252. Accessed December 6 2025."},{"key":"e_1_2_13_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2019.105068"},{"key":"e_1_2_13_35_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e31823ff052"},{"key":"e_1_2_13_36_1","unstructured":"Cressey T.R.et al.Efavirenz pharmacokinetics during the third trimester of pregnancy and postpartum. Efavirenz pharmacokinetics during the third trimester of pregnancy and postpartum (dataset). PKRxiv University of Liverpool (2025)https:\/\/doi.org\/10.58033\/QXYN\u2010NX97."},{"key":"e_1_2_13_37_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.43"},{"key":"e_1_2_13_38_1","unstructured":"Olagunju A.et al.Pharmacogenetics of pregnancy\u2010induced changes in efavirenz pharmacokinetics (dataset). PKRxiv University of Liverpool. (2025)https:\/\/doi.org\/10.58033\/NMMY\u2010PR11."},{"key":"e_1_2_13_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3343"},{"key":"e_1_2_13_40_1","unstructured":"Eniayewu O.et al.Pharmacogenetics of efavirenz exposure in cervicovaginal fluid during pregnancy and postpartum (dataset). PKRxiv University of Liverpool. (2025)https:\/\/doi.org\/10.58033\/G748\u2010JP07."},{"key":"e_1_2_13_41_1","unstructured":"OECD.Guidance document on the characterisation validation and reporting of physiologically based kinetic (PBK) models for regulatory purposes(2021)https:\/\/doi.org\/10.1787\/d0de241f\u2010en. Accessed: December 8 2025."},{"key":"e_1_2_13_42_1","unstructured":"National Institutes of Health.Final NIH Policy for Data Management and Sharing(2020). U.S. Department of Health and Human Services. <https:\/\/grants.nih.gov\/grants\/guide\/notice\u2010files\/NOT\u2010OD\u201021\u2010013.html>. Accessed October 10 2025."},{"key":"e_1_2_13_43_1","unstructured":"Wellcome.Data software and materials management and sharing policy. <https:\/\/wellcome.org\/research\u2010funding\/guidance\/policies\u2010grant\u2010conditions\/data\u2010software\u2010materials\u2010management\u2010and\u2010sharing\u2010policy>. Accessed: December 8 2025."},{"key":"e_1_2_13_44_1","unstructured":"Bill & Melinda Gates Foundation.Open access policy and data sharing requirements. Gates Open Access. <https:\/\/openaccess.gatesfoundation.org\/how\u2010to\u2010comply\/data\u2010sharing\u2010requirements\/>. Accessed December 8 2025."},{"key":"e_1_2_13_45_1","unstructured":"National Institute for Health and Care Research.NIHR position on the sharing of research data<https:\/\/www.nihr.ac.uk\/about\u2010us\/who\u2010we\u2010are\/policies\u2010and\u2010guidelines\/sharing\u2010of\u2010research\u2010data>. Accessed: December 8 2025."},{"key":"e_1_2_13_46_1","unstructured":"European Commission.Open access and research data management under horizon Europe. Research and Innovation. <https:\/\/research\u2010and\u2010innovation.ec.europa.eu\/strategy\/strategy\u2010research\u2010and\u2010innovation\/our\u2010digital\u2010future\/open\u2010science\/open\u2010access_en>. Accessed December 8 2025."},{"key":"e_1_2_13_47_1","unstructured":"European & Developing Countries Clinical Trials Partnership.EDCTP2 policy on clinical trials registration publication and data sharing. <https:\/\/www.edctp.org\/publication\/edctp2\u2010policy\u2010on\u2010clinical\u2010trials\u2010registration\u2010publication\u2010and\u2010data\u2010sharing\/>. Accessed December 8 2025."},{"key":"e_1_2_13_48_1","first-page":"408","article-title":"Current perspectives on data sharing and Open Science in pharmacogenomics","volume":"115","author":"Miao D.N.R.","year":"2024","journal-title":"Clin. Pharmacol. The.r"},{"key":"e_1_2_13_49_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-023-03113-0"},{"key":"e_1_2_13_50_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/civ317"},{"key":"e_1_2_13_51_1","doi-asserted-by":"publisher","DOI":"10.3390\/futurepharmacol4010011"},{"key":"e_1_2_13_52_1","doi-asserted-by":"publisher","DOI":"10.1097\/FTD.0000000000000929"},{"key":"e_1_2_13_53_1","doi-asserted-by":"publisher","DOI":"10.2217\/pgs-2015-0016"},{"key":"e_1_2_13_54_1","doi-asserted-by":"publisher","DOI":"10.1097\/FPC.0000000000000227"},{"key":"e_1_2_13_55_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002895"},{"key":"e_1_2_13_56_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000001755"},{"key":"e_1_2_13_57_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000000968"}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70206","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70206","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70206","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T13:57:44Z","timestamp":1779199064000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70206"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,1]]},"references-count":57,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1002\/cpt.70206"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70206","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,1]]},"assertion":[{"value":"2025-10-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-30","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-01","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}