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However, the risk of toxicity, mainly due to possible multidrug coadministration, makes the therapeutic drug monitoring (TDM) approach crucial for developing personalised therapies and reducing side effects. In the TDM research field, microsampling represents an innovative and effective approach based on the collection and analysis of small sample volumes (&lt;\u2009100 \u03bcL), exhibiting many advantages (such\u00a0as enhanced analyte stability, minimally invasive procedures and simplified\u00a0sample storage and transport) and improving patient adherence. For the first time, an analytical methodology based on microsampling was developed and fully validated for the analysis of lumateperone in capillary blood microsamples, by means of volumetric absorptive microsampling (VAMS) in comparison with plasma analysis, with the future perspective of supporting the TDM of\u00a0psychiatric patients. A reliable and streamlined VAMS protocol was optimised, and an original HPLC\u2013MS\/MS method was developed and validated, granting satisfactory results on simulated samples in terms of linearity, precision, extraction yield and matrix effect. Method reliability was successfully tested by comparing the\u00a0VAMS performance with standard in-tube fluid plasma, and short- and medium-term comparative stability assays confirmed the enhancement of analyte stability obtained in dried microsamples with respect to plasma samples. This is the first analytical method based on microsampling able to provide reliable data when compared to plasma analysis and promising for future TDM applications in patients treated with lumateperone, thus offering significant advantages over conventional blood\/plasma sampling in terms of collection, storage and processing.<\/jats:p>\n                  <jats:p>\n                    <jats:bold>Graphical abstract<\/jats:bold>\n                  <\/jats:p>","DOI":"10.1007\/s00216-025-06169-4","type":"journal-article","created":{"date-parts":[[2025,11,19]],"date-time":"2025-11-19T03:13:41Z","timestamp":1763522021000},"page":"643-653","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Volumetric absorptive microsampling for lumateperone analysis: method validation and stability evaluation"],"prefix":"10.1007","volume":"418","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4738-3590","authenticated-orcid":false,"given":"Elisa","family":"Milandri","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8797-6406","authenticated-orcid":false,"given":"Roberta","family":"Di Lecce","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-6557-3555","authenticated-orcid":false,"given":"Chiara Pia","family":"Iattoni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3766-8755","authenticated-orcid":false,"given":"Andrea","family":"Armirotti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3322-4807","authenticated-orcid":false,"given":"Toma\u017e","family":"Vovk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9631-591X","authenticated-orcid":false,"given":"Roberto","family":"Mandrioli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9310-4957","authenticated-orcid":false,"given":"Michele","family":"Protti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0644-9461","authenticated-orcid":false,"given":"Laura","family":"Mercolini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,11,19]]},"reference":[{"key":"6169_CR1","doi-asserted-by":"publisher","first-page":"525","DOI":"10.1007\/s00228-025-03809-7","volume":"81","author":"A Jarab","year":"2025","unstructured":"Jarab A, Al-Qerem W, Khdour A, Awadallah H, Mimi Y, Khdour M. 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All procedures were carried out in accordance with the ethical standards of the institutional and\/or national research committee. Ethical approval was deemed unnecessary for this study since the samples were anonymised, exclusively used for method development and validation, and no clinical information or patient data were collected or analysed.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Source of biological material and ethics approval"}},{"value":"The authors declare no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}