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In a randomized, controlled trial assessing the efficacy of buprenorphine and morphine in NAS, blood samples were analyzed from a subset of patients receiving buprenorphine along with NAS scores. The data were used to validate and adapt an existing model of buprenorphine in neonates and to identify relationships between buprenorphine or norbuprenorphine pharmacokinetics (PK) and efficacy or safety. The time to NAS stabilization was found to decrease with increasing buprenorphine exposure. This pharmacokinetic\u2013pharmacodynamic (PK\u2010PD) relationship was able to be quantified and adequately described with a mathematical model. The findings confirm a previous PK model of buprenorphine and extend the model to describe the PK of norbuprenorphine and to identify a novel PK\u2010PD relationship of buprenorphine in NAS. This model will allow optimization of dosing strategies in future clinical trials.<\/jats:p>","DOI":"10.1002\/cpt.1064","type":"journal-article","created":{"date-parts":[[2018,3,8]],"date-time":"2018-03-08T07:58:52Z","timestamp":1520495932000},"page":"1029-1037","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":31,"title":["The Pharmacokinetics and Pharmacodynamics of Buprenorphine in Neonatal Abstinence Syndrome"],"prefix":"10.1111","volume":"103","author":[{"given":"Jason N.","family":"Moore","sequence":"first","affiliation":[{"name":"Thomas Jefferson University Philadelphia Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc R.","family":"Gastonguay","sequence":"additional","affiliation":[{"name":"Metrum Research Group Tariffville Connecticut USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chee M.","family":"Ng","sequence":"additional","affiliation":[{"name":"University of Kentucky Lexington Kentucky USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan C.","family":"Adeniyi\u2010Jones","sequence":"additional","affiliation":[{"name":"Thomas Jefferson University Philadelphia Pennsylvania USA"},{"name":"Nemours at Jefferson Philadelphia Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David E.","family":"Moody","sequence":"additional","affiliation":[{"name":"University of Utah Salt Lake City Utah USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenfang B.","family":"Fang","sequence":"additional","affiliation":[{"name":"University of Utah Salt Lake City Utah USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle E.","family":"Ehrlich","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mt. 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