{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,6,12]],"date-time":"2025-06-12T13:45:57Z","timestamp":1749735957640},"reference-count":21,"publisher":"American Society for Microbiology","issue":"4","license":[{"start":{"date-parts":[[2012,4,1]],"date-time":"2012-04-01T00:00:00Z","timestamp":1333238400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2012,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            This study characterized the pharmacokinetic\/pharmacodynamic profiles of the Food and Drug Administration (FDA)-approved telavancin renal dose adjustment schemes. A previously published two-compartment open model with first-order elimination and a combined additive and proportional residual error model derived from 749 adult subjects in 11 clinical trials was used to simulate the individual concentration-time profiles for 10,260 subjects (NONMEM). The dosing regimens simulated were 10 mg\/kg of body weight once daily for individuals with creatinine clearances (CL\n            <jats:sub>CR<\/jats:sub>\n            s) of &gt;50 ml\/min, 7.5 mg\/kg once daily for individuals with CL\n            <jats:sub>CR<\/jats:sub>\n            s of 30 to 50 ml\/min, and 10 mg\/kg every 2 days for those with CL\n            <jats:sub>CR<\/jats:sub>\n            s of &lt;30 ml\/min. The area under the concentration-time curve (AUC) under one dosing interval (AUC\n            <jats:sub>\u03c4<\/jats:sub>\n            ) was computed as dose\/CL. The probability of achieving an AUC\n            <jats:sub>\u03c4<\/jats:sub>\n            \/MIC ratio of \u2265219 was evaluated separately for each renal dosing scheme. Evaluation of the dosing regimens demonstrated similar AUC values across the different renal function groups. For all renal dosing strata, &gt;90% of the simulated subjects achieved an AUC\n            <jats:sub>\u03c4<\/jats:sub>\n            \/MIC ratio of \u2265219 for MIC values as high as 2 mg\/liter. For patients with CL\n            <jats:sub>CR<\/jats:sub>\n            s of &lt;30 ml\/min, the probability of target attainment (PTA) exceeded 90% for both the AUC\n            <jats:sub>0\u201324<\/jats:sub>\n            (AUC from 0 to 24 h) and AUC\n            <jats:sub>24\u201348<\/jats:sub>\n            intervals for MICs of \u22641 mg\/liter. At a MIC of 2 mg\/liter, the PTAs were 89.3% and 23.6% for the AUC\n            <jats:sub>0\u201324<\/jats:sub>\n            and AUC\n            <jats:sub>24\u201348<\/jats:sub>\n            intervals, respectively. The comparable PTA profiles for the three dosing regimens across their respective dosing intervals indicate that the dose adjustments employed in phase III trials for complicated skin and skin structure infections were appropriate.\n          <\/jats:p>","DOI":"10.1128\/aac.00383-11","type":"journal-article","created":{"date-parts":[[2012,1,18]],"date-time":"2012-01-18T05:13:08Z","timestamp":1326863588000},"page":"2062-2066","update-policy":"http:\/\/dx.doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":31,"title":["Telavancin Pharmacokinetics and Pharmacodynamics in Patients with Complicated Skin and Skin Structure Infections and Various Degrees of Renal Function"],"prefix":"10.1128","volume":"56","author":[{"given":"T. P.","family":"Lodise","sequence":"first","affiliation":[{"name":"Albany College of Pharmacy and Health Sciences, Albany, New York, USA"},{"name":"Ordway Research Institute, Albany, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. M.","family":"Butterfield","sequence":"additional","affiliation":[{"name":"Albany College of Pharmacy and Health Sciences, Albany, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. S.","family":"Hegde","sequence":"additional","affiliation":[{"name":"Theravance, Inc., South San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E.","family":"Samara","sequence":"additional","affiliation":[{"name":"PharmaPolaris International, Inc., Danville, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. L.","family":"Barriere","sequence":"additional","affiliation":[{"name":"Theravance, Inc., South San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1086\/653057"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1086\/510079"},{"key":"e_1_3_2_4_2","unstructured":"Astellas Pharma US Inc Theravance Inc. 2009. Vibativ (telavancin) for injection: prescribing information. Astellas Pharma US Inc Deerfield IL and Theravance Inc South San Francisco CA."},{"key":"e_1_3_2_5_2","volume-title":"CLSI document M100-S20","author":"Clinical and Laboratory Standards Institute","year":"2010","unstructured":"Clinical and Laboratory Standards Institute. 2010. Performance standards for antimicrobial susceptibility testing; 20th informational supplement. CLSI document M100-S20. Clinical and Laboratory Standards Institute, Wayne, PA."},{"key":"e_1_3_2_6_2","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1592\/phco.30.1.35","article-title":"Lack of effect of moderate hepatic impairment on the pharmacokinetics of telavancin","volume":"30","author":"Goldberg MR","year":"2010","unstructured":"GoldbergMR WongSL ShawJP KittMM BarriereSL. 2010. Lack of effect of moderate hepatic impairment on the pharmacokinetics of telavancin. Pharmacotherapy 30:35\u201342.","journal-title":"Pharmacotherapy"},{"key":"e_1_3_2_7_2","doi-asserted-by":"crossref","first-page":"806","DOI":"10.1592\/phco.30.8.806","article-title":"Single-dose pharmacokinetics and tolerability of telavancin in elderly men and women","volume":"30","author":"Goldberg MR","year":"2010","unstructured":"GoldbergMR WongSL ShawJP KittMM BarriereSL. 2010. Single-dose pharmacokinetics and tolerability of telavancin in elderly men and women. Pharmacotherapy 30:806\u2013811.","journal-title":"Pharmacotherapy"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00875-07"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.8.3043-3050.2004"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01181-06"},{"key":"e_1_3_2_11_2","volume-title":"20th Eur. Congr. Clin. Microbiol. Infect. Dis.","author":"Lodise TP","year":"2010","unstructured":"LodiseTP PatelN HedgeS ShawJ BarriereS. April 2010. Telavancin pharmacokinetics and pharmacodynamics in patients with complicated skin and skin structure infections with varying degrees of renal function, abstr 468. 20th Eur. Congr. Clin. Microbiol. Infect. Dis., Vienna, Austria."},{"key":"e_1_3_2_12_2","volume-title":"20th Eur. Congr. Clin. Microbiol. Infect. Dis.","author":"Lodise TP","year":"2010","unstructured":"LodiseTP. April 2010. Mouse thigh MRSA infection model data and mathematical modelling to determine telavancin dosing for complicated skin and skin structure infection trials, abstr 469. 20th Eur. Congr. Clin. Microbiol. Infect. Dis., Vienna, Austria."},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkq323"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00296-09"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.05915-11"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.49.1.195-201.2005"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.50.3.862-867.2006"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1086\/587896"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1086\/429914"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.50.2.788-790.2006"},{"key":"e_1_3_2_21_2","volume-title":"Theravance study 103a-PK","author":"Wong SL","year":"2006","unstructured":"WongSL. 25 September 2006. Pharmacokinetics of intravenous telavancin in normal subjects and subjects [with] various degrees of renal dysfunction. Theravance study 103a-PK. Theravance, Inc, South San Francisco, CA."},{"key":"e_1_3_2_22_2","doi-asserted-by":"crossref","first-page":"780","DOI":"10.1093\/jac\/dkn273","article-title":"Multiple-dose pharmacokinetics of intravenous telavancin in healthy male and female subjects","volume":"62","author":"Wong SL","year":"2008","unstructured":"WongSL BarriereSL KittMM GoldbergMR. 2008. Multiple-dose pharmacokinetics of intravenous telavancin in healthy male and female subjects. J. Antimicrob. Chemother. 62:780\u2013783.","journal-title":"J. Antimicrob. Chemother"}],"container-title":["Antimicrobial Agents and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.00383-11","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.00383-11","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,21]],"date-time":"2022-02-21T22:11:25Z","timestamp":1645481485000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/AAC.00383-11"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,4]]},"references-count":21,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2012,4]]}},"alternative-id":["10.1128\/AAC.00383-11"],"URL":"https:\/\/doi.org\/10.1128\/aac.00383-11","relation":{},"ISSN":["0066-4804","1098-6596"],"issn-type":[{"value":"0066-4804","type":"print"},{"value":"1098-6596","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,4]]},"assertion":[{"value":"2011-03-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2011-10-17","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2012-03-16","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}