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Resolvin D1 (RvD1) belongs to a class of lipid\u2010based specialized pro\u2010resolving mediators that showed efficacy in preclinical models of SS. We developed a physiologically\u2010based pharmacokinetic (PBPK) model of RvD1 in mice and optimized the model using plasma and salivary gland pharmacokinetic (PK) studies performed in NOD\/ShiLtJ mice with SS\u2010like features. The predictive performance of the PBPK model was also evaluated with two external datasets from the literature reporting RvD1 PKs. The PBPK model adequately captured the observed concentrations of RvD1 administered at different doses and in different species. The PKs of RvD1 in virtual humans were predicted using the verified PBPK model at various doses (0.01\u201310\u00a0mg\/kg). The first\u2010in\u2010human predictions of RvD1 will be useful for the clinical trial design and translation of RvD1 as an effective treatment strategy for SS.<\/jats:p>","DOI":"10.1111\/cts.12930","type":"journal-article","created":{"date-parts":[[2020,11,17]],"date-time":"2020-11-17T18:48:25Z","timestamp":1605638905000},"page":"683-691","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Predicting Resolvin D1 Pharmacokinetics in Humans with Physiologically\u2010Based Pharmacokinetic Modeling"],"prefix":"10.1111","volume":"14","author":[{"given":"Venkata K.","family":"Yellepeddi","sequence":"first","affiliation":[{"name":"Division of Clinical Pharmacology Department of Pediatrics School of Medicine University of Utah Salt Lake City Utah USA"},{"name":"Department of Pharmaceutics and Pharmaceutical Chemistry College of Pharmacy University of Utah Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaustubh","family":"Parashar","sequence":"additional","affiliation":[{"name":"School of Dentistry University of Utah Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Spencer M.","family":"Dean","sequence":"additional","affiliation":[{"name":"School of Dentistry University of Utah Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin M.","family":"Watt","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology Department of Pediatrics School of Medicine University of Utah Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan E.","family":"Constance","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology Department of Pediatrics School of Medicine University of Utah Salt Lake City Utah USA"},{"name":"Department of Pharmaceutics and Pharmaceutical Chemistry College of Pharmacy University of Utah Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga J.","family":"Baker","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2010Head and Neck Surgery Department of Biochemistry Christopher S. 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