{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T17:00:48Z","timestamp":1788454848992,"version":"build-2803163510"},"reference-count":16,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,8,22]],"date-time":"2025-08-22T00:00:00Z","timestamp":1755820800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Aripiprazole once\u2010monthly (AOM) is approved for the maintenance monotherapy treatment of bipolar I disorder (BP\u2010I) in adults. A previously developed population pharmacokinetic model was validated by applying it to data from patients diagnosed with BP\u2010I. The model was then used to generate aripiprazole exposures for an exposure\u2010response model intended to describe the relationship between aripiprazole exposure and time to recurrence of any mood episode in patients with BP\u2010I. The BP\u2010I data were best described by a continuous model in which higher aripiprazole exposure was associated with a lower risk of recurrence. For each 1\u00a0ng\/mL increase in aripiprazole plasma concentration, the predicted hazard for recurrence decreased by 0.34%. An aripiprazole plasma concentration of 95\u00a0ng\/mL (clinically relevant in schizophrenia) was tested in a separate categorical model and was a significant predictor of time to recurrence (\n                    <jats:italic>P\u00a0<\/jats:italic>\n                    =\u00a0.0270), with a 36% (1.55\u2010fold) decrease in the predicted risk of recurrence with an aripiprazole concentration of \u226595 versus &lt;95\u00a0ng\/mL. Plasma aripiprazole concentration was identified as an important predictor of recurrence in patients diagnosed with BP\u2010I treated with AOM, highlighting the importance of maintenance therapy. A 95\u00a0ng\/mL threshold is relevant in BP\u2010I, but with a smaller effect size compared with that in schizophrenia.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.1580","type":"journal-article","created":{"date-parts":[[2025,8,22]],"date-time":"2025-08-22T19:03:44Z","timestamp":1755889424000},"page":"869-878","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Exposure\u2013Response Analysis for Aripiprazole Once\u2010Monthly in Patients Diagnosed With Bipolar I Disorder"],"prefix":"10.1002","volume":"14","author":[{"given":"Xiaofeng","family":"Wang","sequence":"first","affiliation":[{"name":"Pharmacometrics Otsuka Pharmaceutical Development &amp; Commercialization, Inc.  Princeton NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luann","family":"Phillips","sequence":"additional","affiliation":[{"name":"Simulations Plus, Inc. Clinical Pharmacology and Pharmacometrics Business Unit  Buffalo NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Harlin","sequence":"additional","affiliation":[{"name":"Discovery Research, Early Phase and Translational Medicine Otsuka Pharmaceutical Development &amp; Commercialization, Inc.  Princeton NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karimah S.","family":"Bell Lynum","sequence":"additional","affiliation":[{"name":"Global Medical Affairs Otsuka Pharmaceutical Development &amp; Commercialization, Inc.  Princeton NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Larsen","sequence":"additional","affiliation":[{"name":"Clinical &amp; Quantitative Pharmacology H. Lundbeck A\/S  Valby Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro","family":"Such","sequence":"additional","affiliation":[{"name":"Global Medical Affairs H. Lundbeck A\/S  Valby Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Madera\u2010McDonough","sequence":"additional","affiliation":[{"name":"Global Medical Affairs Otsuka Pharmaceutical Development &amp; Commercialization, Inc.  Princeton NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murat","family":"Yildirim","sequence":"additional","affiliation":[{"name":"Global Medical Affairs H. Lundbeck A\/S  Valby Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ric M.","family":"Procyshyn","sequence":"additional","affiliation":[{"name":"Department of Psychiatry University of British Columbia British Columbia Mental Health and Substance Use Research Institute  Vancouver BC Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Craig","family":"Chepke","sequence":"additional","affiliation":[{"name":"Excel Psychiatric Associates, P.A.  Huntersville NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Passarell","sequence":"additional","affiliation":[{"name":"Simulations Plus, Inc. Clinical Pharmacology and Pharmacometrics Business Unit  Buffalo NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,8,22]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1080\/17425255.2018.1515911"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1022"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.2147\/NDT.S412357"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2025.2456014"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-023-00996-8"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1397"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.16m11201"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/1741-7015-11-127"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopsych.2004.09.022"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2024.01.257"},{"issue":"1","key":"e_1_2_10_12_1","first-page":"9","article-title":"Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: update 2017","volume":"51","author":"Hiemke C","year":"2018","journal-title":"Pharmacopsychiatry"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/20451253241278830"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2023.2219155"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.2147\/NDT.S199048"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/08039488.2020.1841289"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0000000000000523"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1580","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,4]],"date-time":"2025-11-04T08:42:00Z","timestamp":1762245720000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1580"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,22]]},"references-count":16,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2025,11]]}},"alternative-id":["10.1002\/cpdd.1580"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1580","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,22]]},"assertion":[{"value":"2025-03-07","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-17","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-08-22","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}