{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T20:20:32Z","timestamp":1790194832696,"version":"4.1.0"},"reference-count":20,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T00:00:00Z","timestamp":1677628800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T00:00:00Z","timestamp":1677628800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T00:00:00Z","timestamp":1677628800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T00:00:00Z","timestamp":1677628800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T00:00:00Z","timestamp":1677628800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T00:00:00Z","timestamp":1677628800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T00:00:00Z","timestamp":1677628800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmacological and Toxicological Methods"],"published-print":{"date-parts":[[2023,3]]},"DOI":"10.1016\/j.vascn.2023.107253","type":"journal-article","created":{"date-parts":[[2023,2,16]],"date-time":"2023-02-16T12:46:19Z","timestamp":1676551579000},"page":"107253","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":12,"special_numbering":"C","title":["Comparison of validity of standard nonclinical group size selection versus standard clinical group sizes for nonhuman primate QTc prolongation evaluation"],"prefix":"10.1016","volume":"120","author":[{"given":"David","family":"Holdsworth","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Derek D.","family":"Best","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katarina","family":"Haist","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyle","family":"O'Donohue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anson","family":"Phillips","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew M.","family":"Abernathy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Roche","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Derek J.","family":"Leishman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.vascn.2023.107253_bb0005","series-title":"ICH E14: the clinical evaluation of QT\/QTc interval prolongation and proarrhythmic potential for non- antiarrhythmic drugs","author":"Anonymous","year":"2005"},{"key":"10.1016\/j.vascn.2023.107253_bb0010","series-title":"ICH S7B: The non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals","author":"Anonymous","year":"2005"},{"key":"10.1016\/j.vascn.2023.107253_bb0015","series-title":"ICH_E14-S7B Training Material Examples Supplemental File 2022_0331.pdf","author":"Anonymous","year":"2022"},{"key":"10.1016\/j.vascn.2023.107253_bb0020","series-title":"ICH E14 guideline: the clinical evaluation of QT\/QTc interval prolongation and Proarrhythmic potential for non-antiarrhythmic drugs - Questions & Answers","volume":"R3","author":"Anonymous.","year":"2015"},{"key":"10.1016\/j.vascn.2023.107253_bb0025","series-title":"ICH E14\/S7B implementation working group - clinical and nonclinical evaluation of QT\/QTc interval prolongation and Proarrhythmic potential. Questions and Answers","author":"Anonymous.","year":"2022"},{"issue":"3","key":"10.1016\/j.vascn.2023.107253_bb0030","doi-asserted-by":"crossref","first-page":"236","DOI":"10.1002\/pst.454","article-title":"Review of the statistical analysis of the dog telemetry study","volume":"10","author":"Aylott","year":"2011","journal-title":"Pharm. Stat."},{"key":"10.1016\/j.vascn.2023.107253_bb0035","doi-asserted-by":"crossref","DOI":"10.1111\/cts.13103","article-title":"Evaluation of moxifloxacin in canine and non-human primate telemetry assays: Comparison of QTc interval prolongation by timepoint and concentration-QTc analysis","author":"Chui","year":"2021","journal-title":"Clin. Translat. Sci."},{"issue":"2","key":"10.1016\/j.vascn.2023.107253_bb0040","doi-asserted-by":"crossref","first-page":"427","DOI":"10.1093\/toxsci\/kfu198","article-title":"The concordance between nonclinical and phase I clinical cardiovascular assessment from a cross-company data sharing initiative","volume":"142","author":"Ewart","year":"2014","journal-title":"Toxicol. Sci."},{"issue":"8","key":"10.1016\/j.vascn.2023.107253_bb0045","doi-asserted-by":"crossref","first-page":"1152","DOI":"10.1177\/0091270010381498","article-title":"Population pharmacokinetic and concentration--QTc models for moxifloxacin: pooled analysis of 20 thorough QT studies","volume":"51","author":"Florian","year":"2011","journal-title":"J. Clin. Pharmacol."},{"issue":"1","key":"10.1016\/j.vascn.2023.107253_bb0050","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1016\/j.vascn.2013.05.004","article-title":"Preclinical QT safety assessment: Cross-species comparisons and human translation from an industry consortium","volume":"69","author":"Holzgrefe","year":"2014","journal-title":"J. Pharmacol. Toxicol. Methods"},{"key":"10.1016\/j.vascn.2023.107253_bb0055","doi-asserted-by":"crossref","DOI":"10.1016\/j.vascn.2019.106606","article-title":"Exposure-response analysis of drug-induced QT interval prolongation in telemetered monkeys for translational prediction to human","volume":"99","author":"Komatsu","year":"2019","journal-title":"J. Pharmacol. Toxicol. Methods"},{"issue":"3","key":"10.1016\/j.vascn.2023.107253_bb0060","doi-asserted-by":"crossref","first-page":"93","DOI":"10.1016\/j.vascn.2011.08.006","article-title":"Best practice in the conduct of key nonclinical cardiovascular assessments in drug development: Current recommendations from the safety pharmacology society","volume":"65","author":"Leishman","year":"2012","journal-title":"J. Pharmacol. Toxicol. Methods"},{"key":"10.1016\/j.vascn.2023.107253_bb0065","series-title":"EnvStats: An R package for environmental statistics","author":"Millard","year":"2013"},{"issue":"4","key":"10.1016\/j.vascn.2023.107253_bb0070","doi-asserted-by":"crossref","first-page":"606","DOI":"10.1111\/bph.14101","article-title":"Can non-clinical repolarization assays predict the results of clinical thorough QT studies? Results from a research consortium","volume":"175","author":"Park","year":"2018","journal-title":"Br. J. Pharmacol."},{"issue":"1","key":"10.1016\/j.vascn.2023.107253_bb0075","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1093\/toxsci\/kfx125","article-title":"An analysis of the relationship between preclinical and clinical QT interval-related data","volume":"159","author":"Pollard","year":"2017","journal-title":"Toxicol. Sci."},{"key":"10.1016\/j.vascn.2023.107253_bb0080","series-title":"R: A language and environment for statistical computing","author":"R Core Team","year":"2022"},{"key":"10.1016\/j.vascn.2023.107253_bb0085","doi-asserted-by":"crossref","first-page":"69","DOI":"10.1093\/jac\/43.suppl_2.69","article-title":"Pharmacokinetics of the 8-methoxyquinolone, moxifloxacin: A comparison in humans and other mammalian species","volume":"43","author":"Siefert","year":"1999","journal-title":"J. Antimicrob. Chemother."},{"key":"10.1016\/j.vascn.2023.107253_bb0090","article-title":"Translational models and tools to reduce clinical trials and improve regulatory decision making for QTc and Proarrhythmia risk (ICH E14\/S7B updates)","author":"Strauss","year":"2020","journal-title":"Clin. Pharmacol. Ther."},{"key":"10.1016\/j.vascn.2023.107253_bb0095","article-title":"Time for a fully integrated nonclinical-clinical risk assessment to streamline QT prolongation liability determinations: A pharma industry perspective","author":"Vargas","year":"2020","journal-title":"Clin. Pharmacol. Ther."},{"issue":"3","key":"10.1016\/j.vascn.2023.107253_bb0100","doi-asserted-by":"crossref","first-page":"304","DOI":"10.1016\/j.vascn.2011.03.002","article-title":"Pharmacokinetic\u2013pharmacodynamic modelling of the effect of moxifloxacin on QTc prolongation in telemetered cynomolgus monkeys","volume":"63","author":"Watson","year":"2011","journal-title":"J. Pharmacol. Toxicol. Methods"}],"container-title":["Journal of Pharmacological and Toxicological Methods"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1056871923000047?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1056871923000047?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T00:05:39Z","timestamp":1761005139000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1056871923000047"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3]]},"references-count":20,"alternative-id":["S1056871923000047"],"URL":"https:\/\/doi.org\/10.1016\/j.vascn.2023.107253","relation":{},"ISSN":["1056-8719"],"issn-type":[{"value":"1056-8719","type":"print"}],"subject":[],"published":{"date-parts":[[2023,3]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Comparison of validity of standard nonclinical group size selection versus standard clinical group sizes for nonhuman primate QTc prolongation evaluation","name":"articletitle","label":"Article Title"},{"value":"Journal of Pharmacological and Toxicological Methods","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.vascn.2023.107253","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2023 Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}],"article-number":"107253"}}