{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T06:49:42Z","timestamp":1791528582156,"version":"4.3.4"},"reference-count":18,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T00:00:00Z","timestamp":1791417600000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The study aimed to assess the bioequivalence of a new generic orally disintegrating tablet (ODT) formulation containing mirtazapine 30\u00a0mg with the reference formulation, and to support biowaiver for an additional 15\u00a0mg strength. Fifty\u2010five healthy Malaysian males completed an open\u2010label, balanced, randomized, 2\u2010treatment, 2\u2010period, single oral dose study with a 14\u2010day washout period under fasting conditions. Each participant received a single 30\u00a0mg dose of mirtazapine test or reference ODT. Plasma concentrations of mirtazapine up to 72 h post\u2010dose were quantified using a validated high\u2010performance liquid chromatography\u2010tandem mass spectrometry detection method following a liquid\u2010liquid extraction. Non\u2010compartmental analysis was used to derive the pharmacokinetic parameters, which were then compared between the test and reference formulations using a multivariate analysis of variance. The pharmacokinetic parameters of the test formulation were not statistically different from the reference formulation. The 90% confidence intervals of mirtazapine for AUC\n                    <jats:sub>0\u201372<\/jats:sub>\n                    and\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    concentration were within 80%\u2010125% based on the bioequivalence acceptance range criteria. The test and reference formulations of mirtazapine 30\u00a0mg ODT are bioequivalent and well tolerated under fasting conditions. These findings support the extrapolation of bioequivalence and the justification of a biowaiver for the additional mirtazapine ODT 15\u00a0mg strength.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70110","type":"journal-article","created":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T05:59:43Z","timestamp":1791525583000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetic and Bioequivalence of Mirtazapine Orally Disintegrating Tablets: A Randomized, Crossover Study"],"prefix":"10.1002","volume":"15","author":[{"given":"Kai Bin","family":"Liew","sequence":"first","affiliation":[{"name":"Department Faculty of Pharmacy University of Cyberjaya (UoC).  Cyberjaya Selangor Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kar Ming","family":"Yee","sequence":"additional","affiliation":[{"name":"Formulation and R&amp;D Technologies Duopharma Innovation Sdn. Bhd.  Shah Alam Selangor Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeyashanthini","family":"Nalaiya","sequence":"additional","affiliation":[{"name":"Formulation and R&amp;D Technologies Duopharma Innovation Sdn. Bhd.  Shah Alam Selangor Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atiqah","family":"Amran","sequence":"additional","affiliation":[{"name":"Formulation and R&amp;D Technologies Duopharma Innovation Sdn. Bhd.  Shah Alam Selangor Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khairil Aswad","family":"Othman","sequence":"additional","affiliation":[{"name":"Questra Bio\u2010Clinical Research Centre Questra Clinical Research Sdn. Bhd., Permatang Pauh  Pulau Pinang Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,8]]},"reference":[{"issue":"4","key":"e_1_2_8_2_1","first-page":"2412","article-title":"A review on fast dissolving tablets","volume":"5","author":"Aparna P","year":"2018","journal-title":"Indo Am J Pharm Sci"},{"key":"e_1_2_8_3_1","volume-title":"Oral Disintegration Tablets \u2013 An Updated Review","author":"Swamy SAD","year":"2019"},{"issue":"3","key":"e_1_2_8_4_1","doi-asserted-by":"crossref","first-page":"211","DOI":"10.2174\/0122103031291909240317162755","article-title":"Recent advances in orally disintegrating tablet: properties, formulation and production","volume":"14","author":"Yee KM","year":"2024","journal-title":"Drug Deliv Lett"},{"issue":"10","key":"e_1_2_8_5_1","doi-asserted-by":"crossref","first-page":"782","DOI":"10.4088\/JCP.v62n1006","article-title":"Efficacy of mirtazapine for prevention of depressive relapse","volume":"62","author":"Thase ME","year":"2001","journal-title":"J Clin Psychiatry"},{"issue":"5","key":"e_1_2_8_6_1","doi-asserted-by":"crossref","first-page":"358","DOI":"10.4088\/JCP.v62n0509","article-title":"Does mirtazapine have a more rapid onset than SSRIs?","volume":"62","author":"Quitkin FM","year":"2001","journal-title":"J Clin Psychiatry"},{"issue":"1","key":"e_1_2_8_7_1","doi-asserted-by":"crossref","first-page":"S27","DOI":"10.1002\/hup.386","article-title":"Onset of action of antidepressants: results of different analyses","volume":"17","author":"Thompson C","year":"2002","journal-title":"Hum Psychopharmacol"},{"issue":"8","key":"e_1_2_8_8_1","doi-asserted-by":"crossref","first-page":"843","DOI":"10.1177\/0269881107083808","article-title":"A meta\u2010analysis of clinical trials comparing mirtazapine with selective serotonin reuptake inhibitors for the treatment of major depressive disorder","volume":"22","author":"Papakostas GI","year":"2008","journal-title":"J Psychopharmacology"},{"key":"e_1_2_8_9_1","volume-title":"Psychotropic Drug Handout","author":"Stovell K","year":"2005"},{"issue":"6","key":"e_1_2_8_10_1","doi-asserted-by":"crossref","first-page":"1008","DOI":"10.3109\/03639045.2015.1104345","article-title":"Formulation studies for mirtazapine orally disintegrating tablets","volume":"42","author":"Y\u0131ld\u0131z S","year":"2015","journal-title":"Drug Dev Ind Pharm"},{"issue":"4","key":"e_1_2_8_11_1","first-page":"186","article-title":"Recent formulation advances and therapeutic usefulness of orally disintegrating tablets (ODTs)","volume":"8","author":"Chinwala M","year":"2020","journal-title":"Pharmacy (Basel)"},{"issue":"1","key":"e_1_2_8_12_1","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1186\/2008-2231-20-24","article-title":"Formulation and evaluation of microsphere\u2010based orodispersible tablets of itopride HCl","volume":"20","author":"Shah S","year":"2012","journal-title":"DARU J Pharm Sci"},{"issue":"1","key":"e_1_2_8_13_1","first-page":"246","article-title":"P01\u201026 \u2010 clinical perceived differences between mirtazapine conventional tablets and mirtazapine orally disintegrating tablets","volume":"25","author":"De Pedro JM","year":"2010","journal-title":"Eur Psychiatry"},{"issue":"6","key":"e_1_2_8_14_1","doi-asserted-by":"crossref","first-page":"437","DOI":"10.2165\/00044011-200121060-00007","article-title":"Bioequivalence trial of orally disintegrating mirtazapine tablets and conventional oral mirtazapine tablets in healthy volunteers","volume":"21","author":"Van Den Heuvel MW","year":"2001","journal-title":"Clin Drug Investig"},{"issue":"6","key":"e_1_2_8_15_1","doi-asserted-by":"crossref","first-page":"461","DOI":"10.2165\/00003088-200038060-00001","article-title":"Clinical pharmacokinetics of mirtazapine","volume":"38","author":"Timmer CJ","year":"2000","journal-title":"Clin 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A","year":"2021","journal-title":"Clin Pharmacol Drug Dev"},{"key":"e_1_2_8_19_1","unstructured":"Public assessment report: mirtazapine ratiopharm fispersible 15\/30\/45\u00a0mg orodispersible tablets (procedure no. NL\/H\/1103\/001\u2010003\/MR).Medicines Evaluation Board. August 25 2009. Accessed July 30 2026.https:\/\/db.cbg\u2010meb.nl\/pars\/h34985.pdf"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70110","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70110","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70110","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T05:59:46Z","timestamp":1791525586000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70110"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10]]},"references-count":18,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["10.1002\/cpdd.70110"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70110","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10]]},"assertion":[{"value":"2026-06-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-23","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-10-08","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70110"}}