{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T15:23:47Z","timestamp":1788535427011,"version":"build-2803163510"},"reference-count":31,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2021,10,1]],"date-time":"2021-10-01T00:00:00Z","timestamp":1633046400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2021,10,1]],"date-time":"2021-10-01T00:00:00Z","timestamp":1633046400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2021,10,1]],"date-time":"2021-10-01T00:00:00Z","timestamp":1633046400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2021,10,1]],"date-time":"2021-10-01T00:00:00Z","timestamp":1633046400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2021,10,1]],"date-time":"2021-10-01T00:00:00Z","timestamp":1633046400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2021,10,1]],"date-time":"2021-10-01T00:00:00Z","timestamp":1633046400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2021,10,1]],"date-time":"2021-10-01T00:00:00Z","timestamp":1633046400000},"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":["European Journal of Pharmaceutical Sciences"],"published-print":{"date-parts":[[2021,10]]},"DOI":"10.1016\/j.ejps.2021.105923","type":"journal-article","created":{"date-parts":[[2021,7,3]],"date-time":"2021-07-03T20:00:59Z","timestamp":1625342459000},"page":"105923","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":9,"special_numbering":"C","title":["A randomized dose-escalation study on the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of a novel recombinant human albumin in healthy subjects"],"prefix":"10.1016","volume":"165","author":[{"given":"Cuiyun","family":"Li","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Xiang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianqiu","family":"Cheng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tao","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiajia","family":"Mai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiumei","family":"Chi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiuzhu","family":"Gao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanhua","family":"Ding","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junqi","family":"Niu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"3","key":"10.1016\/j.ejps.2021.105923_bib0001","doi-asserted-by":"crossref","first-page":"230","DOI":"10.3350\/cmh.2018.1005","article-title":"KASL clinical practice guidelines for liver cirrhosis: ascites and related complications","volume":"24","year":"2018","journal-title":"Clin. Mol. Hepatol."},{"issue":"1","key":"10.1016\/j.ejps.2021.105923_bib0002","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1002\/hep.1840070124","article-title":"Compensated cirrhosis: natural history and prognostic factors","volume":"7","author":"Gin\u00e9s","year":"1987","journal-title":"Hepatology"},{"issue":"2","key":"10.1016\/j.ejps.2021.105923_bib0003","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1111\/liv.12941","article-title":"\u03b11 and \u03b12-adrenergic agonists on cirrhotic patients with refractory ascites","volume":"36","author":"Ventura-Cots","year":"2016","journal-title":"Liver Int."},{"issue":"11","key":"10.1016\/j.ejps.2021.105923_bib0004","doi-asserted-by":"crossref","first-page":"1385","DOI":"10.1016\/j.cgh.2006.08.007","article-title":"Natural history of patients hospitalized for management of cirrhotic ascites","volume":"4","author":"Planas","year":"2006","journal-title":"Clin. Gastroenterol. Hepatol."},{"issue":"5","key":"10.1016\/j.ejps.2021.105923_bib0005","doi-asserted-by":"crossref","first-page":"1147","DOI":"10.1053\/jhep.2003.50169","article-title":"Randomized trial comparing albumin and saline in the prevention of paracentesis-induced circulatory dysfunction in cirrhotic patients with ascites","volume":"37","author":"Sola-Vera","year":"2003","journal-title":"Hepatology"},{"issue":"2","key":"10.1016\/j.ejps.2021.105923_bib0006","doi-asserted-by":"crossref","first-page":"406","DOI":"10.1016\/j.jhep.2018.03.024","article-title":"Electronic address eee, European association for the Study of the L. EASL clinical practice guidelines for the management of patients with decompensated cirrhosis","volume":"69","year":"2018","journal-title":"J. Hepatol."},{"key":"10.1016\/j.ejps.2021.105923_bib0007","unstructured":"American Association for the Study of Liver Diseases. Practice guideline: management of adult patients with ascites due to cirrhosis: update 2012; 2013. Available from: https:\/\/www.aasld.org\/sites\/default\/files\/2019-06\/AASLDPracticeGuidelineAsciteDuetoCirrhosis."},{"key":"10.1016\/j.ejps.2021.105923_bib0009","doi-asserted-by":"crossref","first-page":"153","DOI":"10.2147\/HMER.S264231","article-title":"Albumin administration is efficacious in the management of patients with cirrhosis: a systematic review of the literature","volume":"12","author":"Zaccherini","year":"2020","journal-title":"Hepat. Med."},{"issue":"1","key":"10.1016\/j.ejps.2021.105923_bib0010","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1111\/liv.13968","article-title":"Long-term administration of human albumin improves survival in patients with cirrhosis and refractory ascites","volume":"39","author":"Di Pascoli","year":"2019","journal-title":"Liver Int."},{"issue":"10138","key":"10.1016\/j.ejps.2021.105923_bib0011","doi-asserted-by":"crossref","first-page":"2417","DOI":"10.1016\/S0140-6736(18)30840-7","article-title":"Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial","volume":"391","author":"Caraceni","year":"2018","journal-title":"Lancet"},{"issue":"6","key":"10.1016\/j.ejps.2021.105923_bib0012","doi-asserted-by":"crossref","first-page":"887","DOI":"10.1093\/bja\/85.6.887","article-title":"Production of human albumin solution: a continually developing colloid","volume":"85","author":"Matejtschuk","year":"2000","journal-title":"Br. J. Anaesth."},{"issue":"4","key":"10.1016\/j.ejps.2021.105923_bib0013","doi-asserted-by":"crossref","first-page":"1172","DOI":"10.1002\/hep.24786","article-title":"Albumin infusion in patients undergoing large-volume paracentesis: a meta-analysis of randomized trials","volume":"55","author":"Bernardi","year":"2012","journal-title":"Hepatology"},{"issue":"6","key":"10.1016\/j.ejps.2021.105923_bib0014","doi-asserted-by":"crossref","first-page":"623","DOI":"10.1080\/15321819.2016.1184163","article-title":"A methodological approach for purification and characterization of human serum albumin","volume":"37","author":"Raoufinia","year":"2016","journal-title":"J. Immunoassay Immunochem."},{"issue":"8","key":"10.1016\/j.ejps.2021.105923_bib0015","doi-asserted-by":"crossref","first-page":"721","DOI":"10.1016\/j.ejim.2013.05.015","article-title":"Clinical indications for the albumin use: still a controversial issue","volume":"24","author":"Caraceni","year":"2013","journal-title":"Eur. J. Intern. Med."},{"issue":"3","key":"10.1016\/j.ejps.2021.105923_bib0016","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1016\/j.mam.2011.12.002","article-title":"Human serum albumin: from bench to bedside","volume":"33","author":"Fanali","year":"2012","journal-title":"Mol. Aspects Med."},{"key":"10.1016\/j.ejps.2021.105923_bib0017","doi-asserted-by":"crossref","first-page":"979","DOI":"10.1016\/j.ijbiomac.2018.11.053","article-title":"Structure, enzymatic activities, glycation and therapeutic potential of human serum albumin: a natural cargo","volume":"123","author":"Rabbani","year":"2019","journal-title":"Int. J. Biol. Macromol."},{"issue":"9","key":"10.1016\/j.ejps.2021.105923_bib0018","doi-asserted-by":"crossref","first-page":"5867","DOI":"10.1002\/jcp.29583","article-title":"Pichia pastoris: a highly successful expression system for optimal synthesis of heterologous proteins","volume":"235","author":"Karbalaei","year":"2020","journal-title":"J. Cell. Physiol."},{"issue":"4","key":"10.1016\/j.ejps.2021.105923_bib0019","doi-asserted-by":"crossref","first-page":"331","DOI":"10.1006\/biol.1998.0163","article-title":"Recombinant human albumin as a stabilizer for biological materials and for the preparation of international reference reagents","volume":"26","author":"Tarelli","year":"1998","journal-title":"Biologicals"},{"issue":"1","key":"10.1016\/j.ejps.2021.105923_bib0020","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1016\/j.jconrel.2011.09.069","article-title":"Impact of albumin on drug delivery\u2013new applications on the horizon","volume":"157","author":"Elsadek","year":"2012","journal-title":"J. Control. Release"},{"issue":"12","key":"10.1016\/j.ejps.2021.105923_bib0021","doi-asserted-by":"crossref","first-page":"5515","DOI":"10.1016\/j.bbagen.2013.04.037","article-title":"Human serum albumin from recombinant DNA technology: challenges and strategies","volume":"1830","author":"Chen","year":"2013","journal-title":"Biochim. Biophys. Acta"},{"key":"10.1016\/j.ejps.2021.105923_bib0022","unstructured":"Food and Drug Administration. Guidance for industry: estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Center for Drug Evaluation and Research (CDER) 2005:7."},{"key":"10.1016\/j.ejps.2021.105923_bib0023","unstructured":"Stedman T. Medical dictionary for the health professions and nursing In.: Lippincott Williams & Wilkins; 2012."},{"issue":"4","key":"10.1016\/j.ejps.2021.105923_bib0024","first-page":"e7780","article-title":"A nomogram for the rapid prediction of hematocrit following blood loss and fluid shifts in neonates, infants, and adults","volume":"12","author":"Egro","year":"2020","journal-title":"Cureus"},{"issue":"6","key":"10.1016\/j.ejps.2021.105923_bib0025","doi-asserted-by":"crossref","first-page":"464","DOI":"10.1007\/s00535-008-2178-5","article-title":"Repeated administration of recombinant human serum albumin caused no serious allergic reactions in patients with liver cirrhosis: a multicenter clinical study","volume":"43","author":"Kasahara","year":"2008","journal-title":"J. Gastroenterol."},{"issue":"5","key":"10.1016\/j.ejps.2021.105923_bib0026","doi-asserted-by":"crossref","first-page":"487","DOI":"10.1016\/j.beem.2017.09.004","article-title":"Regulatory aspects of the human hypothalamus-pituitary-thyroid axis","volume":"31","author":"Roelfsema","year":"2017","journal-title":"Best Pract. Res. Clin. Endocrinol. Metab."},{"issue":"5a","key":"10.1016\/j.ejps.2021.105923_bib0027","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1016\/0002-9343(84)90248-1","article-title":"Goals of nutritional support in acute infections","volume":"76","author":"Tayek","year":"1984","journal-title":"Am. J. Med."},{"issue":"1","key":"10.1016\/j.ejps.2021.105923_bib0028","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1177\/0091270004269646","article-title":"Phase I comparability of recombinant human albumin and human serum albumin","volume":"45","author":"Bosse","year":"2005","journal-title":"J. Clin. Pharmacol."},{"issue":"6383","key":"10.1016\/j.ejps.2021.105923_bib0029","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1038\/358209a0","article-title":"Atomic structure and chemistry of human serum albumin","volume":"358","author":"He","year":"1992","journal-title":"Nature"},{"issue":"11","key":"10.1016\/j.ejps.2021.105923_bib0030","doi-asserted-by":"crossref","first-page":"1228","DOI":"10.1172\/JCI102542","article-title":"The turnover rate of serum albumin in man as measured by I131-tagged albumin","volume":"30","author":"Sterling","year":"1951","journal-title":"J. Clin. Invest."},{"key":"10.1016\/j.ejps.2021.105923_bib0031","series-title":"All About Albumin: Biochemistry, Genetics, and Medical Applications","author":"Peters","year":"1996"},{"issue":"6","key":"10.1016\/j.ejps.2021.105923_bib0032","doi-asserted-by":"crossref","first-page":"424","DOI":"10.1177\/0148607196020006424","article-title":"Albumin kinetics in hypoalbuminemic patients receiving total parenteral nutrition","volume":"20","author":"Spiess","year":"1996","journal-title":"JPEN J. Parenter. Enteral Nutr."}],"container-title":["European Journal of Pharmaceutical Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0928098721002244?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0928098721002244?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T11:58:51Z","timestamp":1760529531000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0928098721002244"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,10]]},"references-count":31,"alternative-id":["S0928098721002244"],"URL":"https:\/\/doi.org\/10.1016\/j.ejps.2021.105923","relation":{},"ISSN":["0928-0987"],"issn-type":[{"value":"0928-0987","type":"print"}],"subject":[],"published":{"date-parts":[[2021,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"A randomized dose-escalation study on the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of a novel recombinant human albumin in healthy subjects","name":"articletitle","label":"Article Title"},{"value":"European Journal of Pharmaceutical Sciences","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.ejps.2021.105923","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2021 Elsevier B.V. All rights reserved.","name":"copyright","label":"Copyright"}],"article-number":"105923"}}