{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T07:02:03Z","timestamp":1768546923155,"version":"3.49.0"},"reference-count":23,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2018,5,11]],"date-time":"2018-05-11T00:00:00Z","timestamp":1525996800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2019,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Dalfampridine is a medication that is approved by the US Food and Drug Administration to improve walking impairments\u00a0in patients\u00a0with multiple\u00a0sclerosis\u00a0(MS). The branded dalfampridine is enormously expensive; hence, the availability of generic dalfampridine will provide better access to the medication, especially for uninsured patients with MS. Bioequivalence studies are demanded by the regulatory authorities to allow the marketing of new generics of dalfampridine. The aim of this study was to assess the bioavailability of the generic (test) and branded (reference) formulations of 10 mg dalfampridine of extended\u2010release tablets after oral administration to healthy adults under fed conditions. The current report methodology was based on a comparative, randomized, single\u2010dose, 2\u2010way crossover open\u2010label study design. Twenty\u2010seven subjects were given a single dose of the test dalfampridine tablet and completed the clinical study. The pharmacokinetic parameters C<jats:sub>max<\/jats:sub> and AUC<jats:sub>0\u2192t,<\/jats:sub> K<jats:sub>el<\/jats:sub>, AUC<jats:sub>0\u2192\u221e<\/jats:sub>, t<jats:sub>max<\/jats:sub>, and t<jats:sub>1\/2el<\/jats:sub> were estimated to prove bioequivalence. The confidence intervals for the log\u2010transformed test\/reference ratios for dalfampridine 100.96% (97.09%\u2013104.97%) and 99.77% (95.81%\u2013103.87%) for C<jats:sub>max<\/jats:sub> and AUC<jats:sub>0\u2192\u221e<\/jats:sub>, respectively, were within the allowed limit specified by the regulatory authorities (80%\u2013125%). Hence, clinically, the test tablet can be prescribed as an alternative to the reference for the indication of improving walking impairments\u00a0in patients\u00a0with MS.<\/jats:p>","DOI":"10.1002\/cpdd.574","type":"journal-article","created":{"date-parts":[[2018,5,11]],"date-time":"2018-05-11T12:13:50Z","timestamp":1526040830000},"page":"355-360","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Comparative Randomized, Single\u2010Dose, Two\u2010Way Crossover Open\u2010Label Study to Determine the Bioequivalence of Two Formulations of Dalfampridine Tablets"],"prefix":"10.1002","volume":"8","author":[{"given":"Abdel Qader","family":"Al Bawab","sequence":"first","affiliation":[{"name":"Faculty of Pharmacy Al\u2010Zaytoonah University of Jordan  Amman Jordan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bashar A.","family":"Alkhalidi","sequence":"additional","affiliation":[{"name":"School of Pharmacy The University of Jordan  Amman Jordan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Esra'a","family":"Albarahmieh","sequence":"additional","affiliation":[{"name":"School of Applied Medical Sciences German Jordanian University  Amman Jordan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sami M.A.","family":"Qassim","sequence":"additional","affiliation":[{"name":"Tabuk Pharmaceuticals  Tabuk Kingdom of Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohammad A. D.","family":"Al\u2010Saifi","sequence":"additional","affiliation":[{"name":"Tabuk Pharmaceuticals  Tabuk Kingdom of Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,5,11]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrneurol.2014.37"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(14)70256-X"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-444-52001-2.00011-X"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0036-1582255"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.parkreldis.2016.02.006"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000002469"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neurol.2015.10.006"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.2174\/1871528114666150529102613"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(14)70231-5"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.2147\/NDT.S10480"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.7224\/1537-2073.2013-031"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1L028"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.2147\/NDT.S10469"},{"key":"e_1_2_8_15_1","first-page":"75","article-title":"Assessing the long\u2010term clinical benefit of prolonged\u2010release fampridine tablets in a real\u2010world setting: a review of 67 cases","volume":"4","author":"Prugger M","year":"2013","journal-title":"Patient Relat Outcome Meas"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0808-z"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1586\/ecp.12.59"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jns.2013.11.011"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.7224\/1537-2073.2013-033"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2012.749221"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.189"},{"key":"e_1_2_8_22_1","unstructured":"Food and Drug Administration.Guidance for Industry: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs \u2014 General Considerations Guidance for Industry.http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/default.htm. 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