{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,13]],"date-time":"2026-11-13T04:24:44Z","timestamp":1794543884995,"version":"4.9.1"},"reference-count":25,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"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":[[2026,12]]},"DOI":"10.1016\/j.vascn.2026.108575","type":"journal-article","created":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T06:46:17Z","timestamp":1789800377000},"page":"108575","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":4,"special_numbering":"C","title":["Weight of evidence in safety pharmacology guidance: A case for explicit probabilistic reasoning in the revision of ICH S7A"],"prefix":"10.1016","volume":"142","author":[{"given":"Derek J.","family":"Leishman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael K.","family":"Pugsley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher P.","family":"Regan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sridharan","family":"Rajamani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael G.","family":"Rolf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric I.","family":"Rossman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Pierre","family":"Valentin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd A.","family":"Wisialowski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jill V.","family":"Nichols","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugo M.","family":"Vargas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.vascn.2026.108575_bb0005","series-title":"Statistical decision theory and Bayesian analysis","author":"Berger","year":"1985"},{"key":"10.1016\/j.vascn.2026.108575_bb0010","doi-asserted-by":"crossref","DOI":"10.3389\/ftox.2024.1353783","article-title":"ICH S1 prospective evaluation study: Weight of evidence approach to predict outcome and value of 2-year rat carcinogenicity studies","volume":"6","author":"Bourcier","year":"2024","journal-title":"Frontiers in Toxicology"},{"key":"10.1016\/j.vascn.2026.108575_bb0015","author":"European Medicines Agency"},{"key":"10.1016\/j.vascn.2026.108575_bb0020","doi-asserted-by":"crossref","DOI":"10.1016\/j.yrtph.2024.105706","article-title":"Reevaluating safety pharmacology respiratory studies within the ICH S7A core battery: A multi-company evaluation of preclinical utility and clinical translation","volume":"153","author":"Friedrichs","year":"2024","journal-title":"Regulatory Toxicology and Pharmacology"},{"key":"10.1016\/j.vascn.2026.108575_bib121","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1016\/j.vascn.2017.02.016","article-title":"GLP in safety pharmacology studies: Report card after 15years","volume":"87","author":"Guth","year":"2017","journal-title":"Journal of Pharmacological and Toxicological Methods"},{"key":"10.1016\/j.vascn.2026.108575_bb0025","author":"International Council for Harmonisation"},{"key":"10.1016\/j.vascn.2026.108575_bb0030","author":"International Council for Harmonisation"},{"key":"10.1016\/j.vascn.2026.108575_bb0035","author":"International Council for Harmonisation"},{"key":"10.1016\/j.vascn.2026.108575_bb0040","author":"International Council for Harmonisation"},{"key":"10.1016\/j.vascn.2026.108575_bb0045","author":"International Council for Harmonisation"},{"key":"10.1016\/j.vascn.2026.108575_bb0050","author":"International Council for Harmonisation"},{"key":"10.1016\/j.vascn.2026.108575_bb0055","doi-asserted-by":"crossref","DOI":"10.1038\/d41573-026-00056-y","article-title":"Unlocking biological barriers: Nonclinical safety considerations for RNA-based complex biologics","author":"Minocherhomji","year":"2026","journal-title":"Nature Reviews Drug Discovery"},{"issue":"7","key":"10.1016\/j.vascn.2026.108575_bb0060","doi-asserted-by":"crossref","first-page":"1382","DOI":"10.1038\/bjp.2008.280","article-title":"Principles of safety pharmacology","volume":"154","author":"Pugsley","year":"2008","journal-title":"British Journal of Pharmacology"},{"issue":"1","key":"10.1016\/j.vascn.2026.108575_bb0065","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1002\/cpt.3204","article-title":"Scientific review of the proarrhythmic risks of oligonucleotide therapeutics: Are dedicated ICH S7B\/E14 studies needed for low-risk modalities?","volume":"116","author":"Qu","year":"2024","journal-title":"Clinical Pharmacology & Therapeutics"},{"key":"10.1016\/j.vascn.2026.108575_bb0070","series-title":"New approach methodologies in safety pharmacology: a pharma industry perspective and roadmap for ICH S7A modernization","author":"Rossman","year":"2026"},{"issue":"2","key":"10.1016\/j.vascn.2026.108575_bb0075","doi-asserted-by":"crossref","first-page":"319","DOI":"10.1002\/cpt.2137","article-title":"Translational models and tools to reduce clinical trials and improve regulatory decision making for QTc and Proarrhythmia risk (ICH E14\/S7B updates)","volume":"109","author":"Strauss","year":"2021","journal-title":"Clinical Pharmacology and Therapeutics"},{"key":"10.1016\/j.vascn.2026.108575_bb0080","doi-asserted-by":"crossref","DOI":"10.3389\/fmed.2025.1537001","article-title":"From guideline to practice: Three years of ICH S11 insights and recommendations","volume":"12","author":"Tavares","year":"2025","journal-title":"Frontiers in Medicine"},{"key":"10.1016\/j.vascn.2026.108575_bb0085","series-title":"Assessment of abuse potential of drugs: Guidance for industry","author":"U.S. Food and Drug Administration","year":"2017"},{"key":"10.1016\/j.vascn.2026.108575_bb0090","doi-asserted-by":"crossref","DOI":"10.3389\/ftox.2024.1377990","article-title":"ICH S1 prospective evaluation study and weight of evidence assessments: Commentary from industry representatives","volume":"6","author":"Vahle","year":"2024","journal-title":"Frontiers in Toxicology"},{"key":"10.1016\/j.vascn.2026.108575_bb0095","doi-asserted-by":"crossref","DOI":"10.1016\/j.yrtph.2026.106096","article-title":"Revisiting ICH S7A after 25 years: Outcomes of a multi-stakeholder workshop and strategic pillars for modernizing safety pharmacology","volume":"169","author":"Valentin","year":"2026","journal-title":"Regulatory Toxicology and Pharmacology"},{"key":"10.1016\/j.vascn.2026.108575_bb0100","doi-asserted-by":"crossref","DOI":"10.1016\/j.vascn.2025.107763","article-title":"Results from an EFPIA, JPMA, PhRMA industry survey on reopening and revamping the ICH S7A guidance on safety and secondary pharmacology","volume":"135","author":"Valentin","year":"2025","journal-title":"Journal of Pharmacological and Toxicological Methods"},{"key":"10.1016\/j.vascn.2026.108575_bb0105","doi-asserted-by":"crossref","DOI":"10.1016\/j.yrtph.2023.105368","article-title":"2000\u20132023 over two decades of ICH S7A: Has the time come for a revamp?","volume":"139","author":"Valentin","year":"2023","journal-title":"Regulatory Toxicology and Pharmacology"},{"key":"10.1016\/j.vascn.2026.108575_bb0110","doi-asserted-by":"crossref","DOI":"10.1016\/j.yrtph.2025.105795","article-title":"Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology","volume":"159","author":"Valentin","year":"2025","journal-title":"Regulatory Toxicology and Pharmacology"},{"issue":"1","key":"10.1016\/j.vascn.2026.108575_bb0115","doi-asserted-by":"crossref","first-page":"91","DOI":"10.1517\/14740338.2013.745851","article-title":"Nonclinical strategy considerations for safety pharmacology: Evaluation of biopharmaceuticals","volume":"12","author":"Vargas","year":"2013","journal-title":"Expert Opinion on Drug Safety"},{"issue":"2","key":"10.1016\/j.vascn.2026.108575_bb0120","doi-asserted-by":"crossref","first-page":"310","DOI":"10.1002\/cpt.2029","article-title":"Time for a fully integrated nonclinical-clinical risk assessment to streamline QT prolongation liability determinations: A pharma industry perspective","volume":"109","author":"Vargas","year":"2021","journal-title":"Clinical Pharmacology and Therapeutics"}],"container-title":["Journal of Pharmacological and Toxicological Methods"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1056871926001681?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1056871926001681?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T12:16:09Z","timestamp":1790424969000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1056871926001681"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,12]]},"references-count":25,"alternative-id":["S1056871926001681"],"URL":"https:\/\/doi.org\/10.1016\/j.vascn.2026.108575","relation":{},"ISSN":["1056-8719"],"issn-type":[{"value":"1056-8719","type":"print"}],"subject":[],"published":{"date-parts":[[2026,12]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Weight of evidence in safety pharmacology guidance: A case for explicit probabilistic reasoning in the revision of ICH S7A","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.2026.108575","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"108575"}}