{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T01:50:38Z","timestamp":1790128238527,"version":"4.0.1"},"reference-count":26,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2013,3,7]],"date-time":"2013-03-07T00:00:00Z","timestamp":1362614400000},"content-version":"vor","delay-in-days":1861,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2008,2]]},"abstract":"<jats:p>We conducted an open\u2010label, parallel\u2010group study of the high purity, mass\u2010produced recombinant human serum albumin (rHSA), derived from the methylotrophic yeast <jats:italic>Pichia pastoris<\/jats:italic>, to compare pharmacokinetics and ensure bioequivalence with plasma\u2010derived human serum albumin (pHSA) in 22 patients with liver cirrhosis. Both rHSA and pHSA groups enrolled 11 patients each, assigned according to predose serum albumin concentrations using the minimization method. Pharmacokinetic and safety profiles for 3\u2010day repeated intravenous infusions at a daily dose of 25 g were evaluated for 8 days. Geometric mean AUC<jats:sub>0\u2013168hr<\/jats:sub> (g\u00b7hr\/dL) was 637.12 and 635.93 in the rHSA and pHSA groups, respectively, with a 90% confidence interval (CI) for the difference (92.9%\u2010108.1%) lying within the bioequivalence range. The other major parameter, geometric mean C<jats:sub>max<\/jats:sub> (g\/dL), was 4.16 and 4.19 in the rHSA and pHSA groups, respectively, with a 90% CI for the difference (92.7%\u2010106.4%). The pHSA group presented with 3 adverse events: 1 case of insomnia, and 2 laboratory abnormalities with no serious adverse events. Results from this study show similar pharmacokinetic profiles following intravenous administration of 25g\/day of rHSA and pHSA for 3 days, indicating bioequivalence.<\/jats:p>","DOI":"10.1177\/0091270007310549","type":"journal-article","created":{"date-parts":[[2008,1,17]],"date-time":"2008-01-17T02:25:00Z","timestamp":1200536700000},"page":"203-208","source":"Crossref","is-referenced-by-count":20,"title":["A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma\u2010derived Human Serum Albumin in Patients With Liver Cirrhosis"],"prefix":"10.1002","volume":"48","author":[{"given":"Kunihiko","family":"Ohnishi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsuhiro","family":"Kawaguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunji","family":"Nakajima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Mori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Ueshima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,3,7]]},"reference":[{"key":"e_1_2_6_2_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1977.03270320038019"},{"key":"e_1_2_6_3_2","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1001\/archinte.1995.00430040041005","article-title":"A paradigm for consensus. 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