{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T21:07:28Z","timestamp":1785791248546,"version":"3.56.0"},"reference-count":23,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2024,11,1]],"date-time":"2024-11-01T00:00:00Z","timestamp":1730419200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2024,11,1]],"date-time":"2024-11-01T00:00:00Z","timestamp":1730419200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2024,11,1]],"date-time":"2024-11-01T00:00:00Z","timestamp":1730419200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2024,11,1]],"date-time":"2024-11-01T00:00:00Z","timestamp":1730419200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2024,11,1]],"date-time":"2024-11-01T00:00:00Z","timestamp":1730419200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2024,11,1]],"date-time":"2024-11-01T00:00:00Z","timestamp":1730419200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2024,11,1]],"date-time":"2024-11-01T00:00:00Z","timestamp":1730419200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"funder":[{"DOI":"10.13039\/501100003593","name":"Conselho Nacional de Desenvolvimento Cientifico e Tecnologico","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003593","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001807","name":"State of Sao Paulo Research Foundation","doi-asserted-by":"publisher","award":["2022\/08406-5"],"award-info":[{"award-number":["2022\/08406-5"]}],"id":[{"id":"10.13039\/501100001807","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Analytica Chimica Acta"],"published-print":{"date-parts":[[2024,11]]},"DOI":"10.1016\/j.aca.2024.343285","type":"journal-article","created":{"date-parts":[[2024,9,26]],"date-time":"2024-09-26T20:41:42Z","timestamp":1727383302000},"page":"343285","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":11,"special_numbering":"C","title":["Measurement uncertainty for &lt;711&gt; Dissolution tests using Monte Carlo methods \u2013 Uncertainties arising from sampling and analytical steps"],"prefix":"10.1016","volume":"1330","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0337-7167","authenticated-orcid":false,"given":"Maisa Torres","family":"Martins","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felipe Rebello","family":"Louren\u00e7o","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"3","key":"10.1016\/j.aca.2024.343285_bib1","article-title":"Development and validation of dissolution procedures","volume":"1","author":"Vaghela","year":"2011","journal-title":"J. Appl. Pharmaceut. Sci."},{"issue":"7","key":"10.1016\/j.aca.2024.343285_bib2","doi-asserted-by":"crossref","DOI":"10.1590\/S0103-50532011000700011","article-title":"Optimization of a new dissolution test for oxcarbazepine capsules using mixed-level factorial design","volume":"22","author":"Polonini","year":"2011","journal-title":"J. Braz. Chem. Soc."},{"issue":"1","key":"10.1016\/j.aca.2024.343285_bib3","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpha.2013.11.001","article-title":"Measurement uncertainty in pharmaceutical analysis and its application","volume":"4","author":"Traple","year":"2014","journal-title":"Journal of Pharmaceutical Analysis"},{"key":"10.1016\/j.aca.2024.343285_bib4","series-title":"Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (ANVISA)","author":"Brasileira","year":"2019"},{"key":"10.1016\/j.aca.2024.343285_bib5","series-title":"United States Pharmacopeial Convention","year":"2021"},{"key":"10.1016\/j.aca.2024.343285_bib6","series-title":"Estimativa de incertezas de medi\u00e7\u00f5es e suas aplica\u00e7\u00f5es nas an\u00e1lises de medicamentos","author":"Louren\u00e7o","year":"2018"},{"key":"10.1016\/j.aca.2024.343285_bib7","series-title":"Joint Committee for Guides in Metrology (Working Group 1)","article-title":"Guide to the expression of uncertainty in measurement","year":"2008"},{"key":"10.1016\/j.aca.2024.343285_bib8","series-title":"Quantifying Uncertainty in Analytical Measurement","year":"2012"},{"key":"10.1016\/j.aca.2024.343285_bib9","series-title":"Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria. Resolu\u00e7\u00e3o n\u00ba 31, de 11 de agosto de 2010. Disp\u00f5e sobre a realiza\u00e7\u00e3o de Estudos de Equivalencia Farmaceutica e do Perfil de Dissolu\u00e7\u00e3o Comparativo","year":"2010"},{"key":"10.1016\/j.aca.2024.343285_bib10","series-title":"Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria. Resolu\u00e7\u00e3o n\u00ba 166, de 24 de julho de 2017. Disp\u00f5e sobre a valida\u00e7\u00e3o de m\u00e9todos anal\u00edticos","year":"2017"},{"issue":"6","key":"10.1016\/j.aca.2024.343285_bib11","doi-asserted-by":"crossref","DOI":"10.1002\/wics.1314","article-title":"Why the Monte Carlo method is so important today","volume":"6","author":"Kroese","year":"2014","journal-title":"Wiley Interdisciplinary Reviews: Comput. Stat."},{"key":"10.1016\/j.aca.2024.343285_bib12","series-title":"2008 Winter Simulation Conference","first-page":"91","article-title":"Introduction to Monte Carlo simulation","author":"Raychaudhuri","year":"2008"},{"issue":"7","key":"10.1016\/j.aca.2024.343285_bib13","doi-asserted-by":"crossref","DOI":"10.1007\/s00216-011-5698-4","article-title":"A Monte Carlo approach for estimating measurement uncertainty using standard spreadsheet software","volume":"402","author":"Chew","year":"2012","journal-title":"Anal. Bioanal. Chem."},{"issue":"6","key":"10.1016\/j.aca.2024.343285_bib14","doi-asserted-by":"crossref","first-page":"1571","DOI":"10.1590\/S0100-40422009000600041","article-title":"Methodology validation for evaluation of the uncertainty in the calibration curves better adjusted for second-degree polynomials","volume":"32","author":"Oliveira","year":"2009","journal-title":"Quim. Nova"},{"key":"10.1016\/j.aca.2024.343285_bib15","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2022.115080","article-title":"Definition of multivariate acceptance limits (guard-bands) applied to pharmaceutical equivalence assessment","volume":"222","author":"da Silva","year":"2023","journal-title":"J. Pharmaceut. Biomed. Anal."},{"key":"10.1016\/j.aca.2024.343285_bib16","doi-asserted-by":"crossref","DOI":"10.1016\/j.measurement.2018.01.048","article-title":"Using measurement uncertainty to assess the fitness for purpose of an HPLC analytical method in the pharmaceutical industry","volume":"119","author":"Separovic","year":"2018","journal-title":"Measurement: Journal of the International Measurement Confederation"},{"key":"10.1016\/j.aca.2024.343285_bib17","series-title":"Eurachem\/CITAC Guide: Measurement Uncertainty Arising from Sampling [Internet]","author":"Rampsey","year":"2019"},{"issue":"6","key":"10.1016\/j.aca.2024.343285_bib18","doi-asserted-by":"crossref","first-page":"885","DOI":"10.1590\/S0100-40422013000600025","article-title":"Least saqures regression with errors in both variables: case studies","volume":"36","author":"Oliveira","year":"2013","journal-title":"Quim. Nova"},{"issue":"2","key":"10.1016\/j.aca.2024.343285_bib19","doi-asserted-by":"crossref","first-page":"560","DOI":"10.5740\/jaoacint.11-018","volume":"95","author":"Oliveira","year":"2012","journal-title":"J. AOAC Int."},{"issue":"9","key":"10.1016\/j.aca.2024.343285_bib20","first-page":"4955","article-title":"Evaluation of measurement uncertainty of dissolution tests by the ISO-GUM approach and Monte-Carlo simulation","volume":"64","author":"Haidara","year":"2021","journal-title":"Egypt. J. Chem."},{"key":"10.1016\/j.aca.2024.343285_bib21","doi-asserted-by":"crossref","DOI":"10.1016\/j.microc.2023.109552","article-title":"Measurement uncertainty arising from sampling and analytical steps of dissolution test of glyburide tablets","volume":"196","author":"Sano","year":"2024","journal-title":"Microchem. J."},{"key":"10.1016\/j.aca.2024.343285_bib22","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2023.115501","article-title":"Measurement uncertainty arising from sampling and analytical steps of dissolution test of prednisone tablets","volume":"234","author":"Sano","year":"2023","journal-title":"J. Pharmaceut. Biomed. Anal."},{"issue":"3","key":"10.1016\/j.aca.2024.343285_bib24","doi-asserted-by":"crossref","DOI":"10.1023\/A:1016212804288","article-title":"A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability","volume":"12","author":"Amidon","year":"1995","journal-title":"Pharmaceut. Res.: An Official Journal of the American Association of Pharmaceutical Scientists"}],"container-title":["Analytica Chimica Acta"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0003267024010869?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0003267024010869?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T16:33:50Z","timestamp":1777394030000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0003267024010869"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11]]},"references-count":23,"alternative-id":["S0003267024010869"],"URL":"https:\/\/doi.org\/10.1016\/j.aca.2024.343285","relation":{},"ISSN":["0003-2670"],"issn-type":[{"value":"0003-2670","type":"print"}],"subject":[],"published":{"date-parts":[[2024,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Measurement uncertainty for <711> Dissolution tests using Monte Carlo methods \u2013 Uncertainties arising from sampling and analytical steps","name":"articletitle","label":"Article Title"},{"value":"Analytica Chimica Acta","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.aca.2024.343285","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"343285"}}