{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T05:06:36Z","timestamp":1745903196367},"reference-count":27,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2017,5,31]],"date-time":"2017-05-31T00:00:00Z","timestamp":1496188800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Teva Branded Pharmaceutical Products R&D"},{"name":"Eagle Pharmaceuticals"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Bendamustine hydrochloride (BDM) is approved in the United States to treat chronic lymphocytic leukemia and relapsed indolent B\u2010cell non\u2010Hodgkin lymphoma. The first formulation marketed in the United States (original BDM) was a lyophilized product requiring reconstitution prior to dilution to the final admixture. A liquid formulation of BDM was subsequently introduced that did not require reconstitution before dilution. Both formulations are administered as a 500 mL admixture with a recommended infusion time of 30 or 60 minutes for chronic lymphocytic leukemia and indolent B\u2010cell non\u2010Hodgkin lymphoma, respectively. A newer liquid BDM formulation (rapid BDM) is a ready\u2010to\u2010dilute solution not requiring reconstitution that dilutes into an admixture of only 50 mL and can be safely administered in a shorter infusion time (10 minutes). Rapid BDM admixture also has longer stability at room temperature than both lyophilized and liquid BDM formulations (6 vs 2 to 3 hours). This phase 1, open\u2010label, randomized, crossover (3\u2010period, partially replicated) study, conducted in \u201cend\u2010of\u2010life\u201d cancer patients at 10 oncology centers in the United States, demonstrates that rapid BDM is bioequivalent to original BDM as determined by area under the curve. Expected differences in maximum plasma concentration and time to maximum plasma concentration were observed between study treatments, given the substantially shorter infusion time of rapid BDM. No clinically relevant differences in other evaluated pharmacokinetic parameters were found. Rapid BDM infusions were safe and tolerable for cancer patients in this study. The overall safety profiles of the 2 BDM formulations were comparable, with no new safety signals identified and no differences in infusion\u2010related adverse events.<\/jats:p>","DOI":"10.1002\/jcph.942","type":"journal-article","created":{"date-parts":[[2017,5,31]],"date-time":"2017-05-31T15:32:42Z","timestamp":1496244762000},"page":"1400-1408","source":"Crossref","is-referenced-by-count":4,"title":["Safety and Pharmacokinetics of Bendamustine Rapid\u2010Infusion Formulation"],"prefix":"10.1002","volume":"57","author":[{"given":"Eric M.","family":"Cheung","sequence":"first","affiliation":[{"name":"The Oncology Institute  Long Beach CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William J.","family":"Edenfield","sequence":"additional","affiliation":[{"name":"Greenville Health System Cancer Institute  Greenville SC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bassam","family":"Mattar","sequence":"additional","affiliation":[{"name":"Cancer Center of Kansas  Wichita KS USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen P.","family":"Anthony","sequence":"additional","affiliation":[{"name":"Texas Oncology  Dallas TX USA"},{"name":"Arizona Oncology  Sedona AZ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter J.","family":"Mutch","sequence":"additional","affiliation":[{"name":"ICON plc  Marlow UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"Chanas","sequence":"additional","affiliation":[{"name":"Eagle Pharmaceuticals, Inc  Woodcliff Lake NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Smith","sequence":"additional","affiliation":[{"name":"Eagle Pharmaceuticals, Inc  Woodcliff Lake NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrian","family":"Hepner","sequence":"additional","affiliation":[{"name":"Eagle Pharmaceuticals, Inc  Woodcliff Lake NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,5,31]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.24714"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjh.12000"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.lungcan.2006.09.029"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.cad.0000175587.31940.19"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-015-2727-6"},{"key":"e_1_2_7_7_1","unstructured":"TREANDA\u00ae(bendamustine hydrochloride) [prescribing information]. 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