{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T02:28:39Z","timestamp":1772159319024,"version":"3.50.1"},"reference-count":24,"publisher":"Elsevier BV","issue":"1","license":[{"start":{"date-parts":[[2013,10,1]],"date-time":"2013-10-01T00:00:00Z","timestamp":1380585600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Regulatory Toxicology and Pharmacology"],"published-print":{"date-parts":[[2013,10]]},"DOI":"10.1016\/j.yrtph.2013.07.002","type":"journal-article","created":{"date-parts":[[2013,7,11]],"date-time":"2013-07-11T00:18:08Z","timestamp":1373501888000},"page":"89-97","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":10,"title":["Use of low-dose clinical pharmacodynamic and pharmacokinetic data to establish an occupational exposure limit for dapagliflozin, a potent inhibitor of the renal sodium glucose co-transporter 2"],"prefix":"10.1016","volume":"67","author":[{"given":"Janet C.","family":"Gould","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sreeneeranj","family":"Kasichayanula","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David C.","family":"Shepperly","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David W.","family":"Boulton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"issue":"9733","key":"10.1016\/j.yrtph.2013.07.002_b0005","doi-asserted-by":"crossref","first-page":"2223","DOI":"10.1016\/S0140-6736(10)60407-2","article-title":"Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial","volume":"375","author":"Bailey","year":"2010","journal-title":"Lancet"},{"issue":"1","key":"10.1016\/j.yrtph.2013.07.002_b0010","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1006\/faat.1993.1001","article-title":"Improvements in quantitative noncancer risk assessment. Sponsored by the risk assessment specialty section of the society of toxicology","volume":"20","author":"Beck","year":"1993","journal-title":"Fundamental and Applied Toxicology: Official Journal of the Society of Toxicology"},{"issue":"5","key":"10.1016\/j.yrtph.2013.07.002_b0015","doi-asserted-by":"crossref","first-page":"852","DOI":"10.1038\/sj.ki.5000194","article-title":"Familial renal glucosuria: SLC5A2 mutation analysis and evidence of salt-wasting","volume":"69","author":"Calado","year":"2006","journal-title":"Kidney International"},{"key":"10.1016\/j.yrtph.2013.07.002_b0020","unstructured":"EPA, 2002. Environmental protection agency. A review of the reference dose and reference concentration processes. EPA\/600\/P-02\/002F. Available from: <http:\/\/www.epa.gov\/raf\/publications\/pdfs\/rfd-final.pdf> (accessed 29.09.12)."},{"key":"10.1016\/j.yrtph.2013.07.002_b0025","unstructured":"EPA, 2011. Environmental protection agency. Exposure factors handbook EPA\/600\/R-090\/052F, Available from: <http:\/\/hero.epa.gov\/index.cfm?action=reference.download&reference_id=786546> (accessed 29.09.12)."},{"key":"10.1016\/j.yrtph.2013.07.002_b0030","unstructured":"FDA, 2005. Guidance for industry: estimating the maximum safe dose in initial clinical trials for therapeutics in adult healthy volunteers. Available from: <http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM078932.pdf> J:\\!GUIDANC\\5541fnlcln1.doc U.S. Department of Health and Human Services Food and Drug AdministrationCenter for Drug Evaluation and Research Pharmacology and Toxicology, 2005."},{"issue":"11","key":"10.1016\/j.yrtph.2013.07.002_b0035","doi-asserted-by":"crossref","first-page":"2893","DOI":"10.1093\/ndt\/gfh426","article-title":"A novel SGLT2 mutation in a patient with autosomal recessive renal glucosuria","volume":"19","author":"Francis","year":"2004","journal-title":"Nephrology, Dialysis, Transplantation: Official Publication of the European Dialysis and Transplant Association \u2013 European Renal Association"},{"issue":"6","key":"10.1016\/j.yrtph.2013.07.002_b0040","doi-asserted-by":"crossref","first-page":"1723","DOI":"10.2337\/db07-1472","article-title":"Dapagliflozin, a selective SGLT2 inhibitor, improves glucose homeostasis in normal and diabetic rats","volume":"57","author":"Han","year":"2008","journal-title":"Diabetes"},{"key":"10.1016\/j.yrtph.2013.07.002_b0045","unstructured":"ICH, 2009. International committee on harmonisation of technical requirements for registration of pharmaceuticals for human use. q3c residual solvents. Appendix 3 Methods for establishing exposure limits 2009. Available from: <http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Quality\/Q3C\/Step4\/Q3C_R5_Step4.pdf> (accessed 29.09.12)."},{"key":"10.1016\/j.yrtph.2013.07.002_b0050","first-page":"S2","article-title":"Disposition and mass balance of [14C]-dapagliflozin after single oral dose in healthy male volunteers","volume":"10","author":"Kasichayanula","year":"2008","journal-title":"The AAPS Journal"},{"issue":"5","key":"10.1016\/j.yrtph.2013.07.002_b0055","doi-asserted-by":"crossref","first-page":"520","DOI":"10.1038\/clpt.2008.251","article-title":"Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glucosuria in healthy subjects","volume":"85","author":"Komoroski","year":"2009","journal-title":"Clinical Pharmacology and Therapeutics"},{"issue":"5","key":"10.1016\/j.yrtph.2013.07.002_b0060","doi-asserted-by":"crossref","first-page":"513","DOI":"10.1038\/clpt.2008.250","article-title":"Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus","volume":"85","author":"Komoroski","year":"2009","journal-title":"Clinical Pharmacology and Therapeutics"},{"key":"10.1016\/j.yrtph.2013.07.002_b0065","doi-asserted-by":"crossref","first-page":"314","DOI":"10.1016\/0273-2300(90)90030-F","article-title":"A new approach to deriving community exposure guidelines from \u201cno-observed-adverse-effect-levels\u201d","volume":"11","author":"Lewis","year":"1990","journal-title":"Regulatory Toxicology and Pharmacology"},{"issue":"4","key":"10.1016\/j.yrtph.2013.07.002_b0070","doi-asserted-by":"crossref","first-page":"650","DOI":"10.2337\/dc08-1863","article-title":"Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes","volume":"32","author":"List","year":"2009","journal-title":"Diabetes Care"},{"key":"10.1016\/j.yrtph.2013.07.002_b0075","series-title":"New Concepts in Safety Evaluation","article-title":"Concepts in health evaluation of commercial and industrial chemicals","author":"McNamara","year":"1976"},{"key":"10.1016\/j.yrtph.2013.07.002_b0080","first-page":"560","article-title":"Scientific basis for uncertainty factors used to establish occupational exposure limits for pharamceutical active ingredients","volume":"5","author":"Naumann","year":"1995","journal-title":"Human and Ecological Risk Assessment"},{"issue":"3","key":"10.1016\/j.yrtph.2013.07.002_b0085","doi-asserted-by":"crossref","first-page":"405","DOI":"10.1124\/dmd.109.029165","article-title":"In vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium-glucose cotransporter type II inhibitor, in animals and humans","volume":"38","author":"Obermeier","year":"2010","journal-title":"Drug Metabolism and Disposition: The Biological Fate of Chemicals"},{"issue":"3","key":"10.1016\/j.yrtph.2013.07.002_b0090","first-page":"156","article-title":"Complete absence of tubular glucose reabsorption: a new type of renal glucosuria (type 0)","volume":"27","author":"Oemar","year":"1987","journal-title":"Clinical Nephrology"},{"key":"10.1016\/j.yrtph.2013.07.002_b0095","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1006\/rtph.1997.1195","article-title":"Human variability and noncancer risk assessment \u2013 an analysis of the default uncertainty factor","volume":"27","author":"Renwick","year":"1998","journal-title":"Regulatory Toxicology and Pharmacology"},{"key":"10.1016\/j.yrtph.2013.07.002_b0100","series-title":"Clinical Pharmacokinetics, Concepts and Applications","author":"Rowland","year":"1989"},{"issue":"6","key":"10.1016\/j.yrtph.2013.07.002_b0105","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1080\/15298668891379792","article-title":"Establishing airborne exposure control limits in the pharmaceutical industry","volume":"49","author":"Sargent","year":"1988","journal-title":"American Industrial Hygiene Association Journal"},{"issue":"9","key":"10.1016\/j.yrtph.2013.07.002_b0110","doi-asserted-by":"crossref","first-page":"2394","DOI":"10.1093\/ndt\/gfh366","article-title":"Long-term outcome of renal glucosuria type 0: the original patient and his natural history","volume":"19","author":"Scholl-Burgi","year":"2004","journal-title":"Nephrology, Dialysis, Transplantation: Official Publication of the European Dialysis and Transplant Association \u2013 European Renal Association"},{"key":"10.1016\/j.yrtph.2013.07.002_b0115","doi-asserted-by":"crossref","first-page":"1059","DOI":"10.1080\/10807039991289347","article-title":"Establishing data-derived adjustment factors from published pharmaceutical clinical trial data","volume":"5","author":"Silverman","year":"1999","journal-title":"Human and Ecological Risk Assessment"},{"issue":"11","key":"10.1016\/j.yrtph.2013.07.002_b0120","doi-asserted-by":"crossref","first-page":"1485","DOI":"10.1517\/13543770903337828","article-title":"Evolution of sodium glucose co-transporter 2 inhibitors as anti-diabetic agents","volume":"19","author":"Washburn","year":"2009","journal-title":"Expert Opinion on Therapeutic Patents"}],"container-title":["Regulatory Toxicology and Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0273230013001049?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0273230013001049?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2018,10,14]],"date-time":"2018-10-14T13:26:53Z","timestamp":1539523613000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0273230013001049"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,10]]},"references-count":24,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2013,10]]}},"alternative-id":["S0273230013001049"],"URL":"https:\/\/doi.org\/10.1016\/j.yrtph.2013.07.002","relation":{},"ISSN":["0273-2300"],"issn-type":[{"value":"0273-2300","type":"print"}],"subject":[],"published":{"date-parts":[[2013,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Use of low-dose clinical pharmacodynamic and pharmacokinetic data to establish an occupational exposure limit for dapagliflozin, a potent inhibitor of the renal sodium glucose co-transporter 2","name":"articletitle","label":"Article Title"},{"value":"Regulatory Toxicology and Pharmacology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.yrtph.2013.07.002","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Copyright \u00a9 2013 Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}