{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,7,15]],"date-time":"2024-07-15T18:38:24Z","timestamp":1721068704521},"reference-count":18,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2003,6,6]],"date-time":"2003-06-06T00:00:00Z","timestamp":1054857600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Biopharm &amp; Drug Disp"],"published-print":{"date-parts":[[2003,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>A randomized, two\u2010way, crossover, bioequivalence study was conducted in 24 fasting, healthy, male volunteers to compare two brands of furosemide 40 mg tablets, Salurin (Julphar, UAE) as test and Lasix (Hoechst AG, Germany) as reference product. The study was performed at the International Pharmaceutical Research Centre (IPRC), in a joint venture with Al\u2010Mowasah Hospital, Amman, Jordan. One tablet of either formulation was administered with 240 ml of water after a 10 h overnight fast. After dosing, serial blood samples were collected for a period of 12 h. Plasma harvested from blood was analysed for furosemide by a validated HPLC method. Various pharmacokinetic parameters including <jats:italic>AUC<\/jats:italic><jats:sub>0\u2013t<\/jats:sub>, <jats:italic>AUC<\/jats:italic><jats:sub>0\u2013\u221d<\/jats:sub>, <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>, <jats:italic>T<\/jats:italic><jats:sub>max<\/jats:sub>, <jats:italic>T<\/jats:italic><jats:sub>1\/2<\/jats:sub>, and elimination rate constant were determined from plasma concentrations of both formulations. Statistical modules (ANOVA and 90% confidence intervals) were applied to <jats:italic>AUC<\/jats:italic><jats:sub>0\u2013t<\/jats:sub>, <jats:italic>AUC<\/jats:italic><jats:sub>0\u2212\u221d<\/jats:sub>, and <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> to assess the bioequivalence of the two brands which revealed no significant difference between them, and 90% CI fell within the US FDA accepted bioequivalence range of 80%\u2013125%. Based on these statistical inferences, Salurin was found to be bioequivalent to Lasix. Copyright \u00a9 2003 John Wiley &amp; Sons, Ltd.<\/jats:p>","DOI":"10.1002\/bdd.361","type":"journal-article","created":{"date-parts":[[2003,9,9]],"date-time":"2003-09-09T13:24:10Z","timestamp":1063113850000},"page":"245-249","source":"Crossref","is-referenced-by-count":6,"title":["Bioequivalence evaluation of two brands of furosemide 40mg tablets (Salurin and Lasix) in healthy human volunteers"],"prefix":"10.1002","volume":"24","author":[{"given":"Naji","family":"Najib","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nasir","family":"Idkaidek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Beshtawi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohammed","family":"Bader","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isra'","family":"Admour","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. Mahmood","family":"Alam","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Q.","family":"Zaman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruwayda","family":"Dham","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2003,6,6]]},"reference":[{"key":"e_1_2_1_2_2","first-page":"72","article-title":"A distribution\u2010free procedure for the statistical analysis of bioequivalence studies","volume":"28","author":"Hauschke D","year":"1990","journal-title":"Int J Clin Pharmacol Ther Toxicol"},{"issue":"1","key":"e_1_2_1_3_2","first-page":"S1","article-title":"Striving for standards in bioequivalence assessment: a review","volume":"30","author":"Schulz HU","year":"1992","journal-title":"Int J Clin Pharmacol Ther Toxicol"},{"key":"e_1_2_1_4_2","unstructured":"Index Nominum: International Drug Directory. Edited by the Swiss Pharmaceutical Society\u00a92000. medpharm Scientific Publishers Stuttgart Germany Micromedex Inc Denver CO Vol. 104 expires 6\/2002."},{"key":"e_1_2_1_5_2","first-page":"706","volume-title":"Goodman and Gilman's The Pharmacologic Basis of Therapeutics","author":"Jackson EK","year":"1996"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-199018050-00004"},{"key":"e_1_2_1_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0031-3955(16)36880-8"},{"key":"e_1_2_1_8_2","first-page":"174","article-title":"Loop diuretics","volume":"10","author":"Greger R","year":"1987","journal-title":"Renal Physiol"},{"key":"e_1_2_1_9_2","unstructured":"Product Information: Lasix(R) furosemide. Hoechst\u2010Marion\u2010Roussel Pharmaceuticals Somerville NJ USA (PI revised 1\/96) reviewed 1\/2000; Micromedex Inc Denver CO Vol. 104 expires 6\/2002."},{"key":"e_1_2_1_10_2","volume-title":"Goodman and Gilman's The Pharmacological Basis of Therapeutics","author":"Gilman AG","year":"1990"},{"key":"e_1_2_1_11_2","volume-title":"Drug Evaluations Subscription","author":"AMA Department of Drugs","year":"1990"},{"key":"e_1_2_1_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/cpt1974156588"},{"key":"e_1_2_1_13_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-199528050-00005"},{"key":"e_1_2_1_14_2","volume-title":"Handbook of Clinical Drug Data","author":"Knoben JE","year":"1988"},{"key":"e_1_2_1_15_2","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.1982.101"},{"key":"e_1_2_1_16_2","first-page":"249","article-title":"Analytical method validation: bioavailability, bioequivalence and pharmacokinetic studies","volume":"16","author":"Shah VP","year":"1992","journal-title":"Eur J Drug Metab Pharmacokin"},{"key":"e_1_2_1_17_2","unstructured":"KineticaTM2000.Version 3.0 Innaphase User Manual 1999."},{"key":"e_1_2_1_18_2","unstructured":"Bioavailability and Bioequivalence Studies for Orally Administered Drug Products\u2013General Consideration . US Department of Health and Human Service Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) October2000."},{"key":"e_1_2_1_19_2","volume-title":"Design and Analysis of Bioavailability and Bioequivalence Studies","author":"Chow CS","year":"1992"}],"container-title":["Biopharmaceutics &amp; Drug Disposition"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fbdd.361","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bdd.361","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,16]],"date-time":"2023-11-16T21:43:53Z","timestamp":1700171033000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/bdd.361"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2003,6,6]]},"references-count":18,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2003,9]]}},"alternative-id":["10.1002\/bdd.361"],"URL":"https:\/\/doi.org\/10.1002\/bdd.361","archive":["Portico"],"relation":{},"ISSN":["0142-2782","1099-081X"],"issn-type":[{"value":"0142-2782","type":"print"},{"value":"1099-081X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2003,6,6]]}}}