{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T02:35:24Z","timestamp":1790562924131,"version":"4.1.0"},"reference-count":25,"publisher":"American Society for Microbiology","issue":"6","license":[{"start":{"date-parts":[[2018,5,25]],"date-time":"2018-05-25T00:00:00Z","timestamp":1527206400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2018,6,1]],"date-time":"2018-06-01T00:00:00Z","timestamp":1527811200000},"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":[[2018,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Rezafungin (CD101) is a novel echinocandin antifungal agent currently in clinical development for the treatment of candidemia and invasive candidiasis. Rezafungin has potent\n                    <jats:italic>in vitro<\/jats:italic>\n                    activity against\n                    <jats:named-content content-type=\"genus-species\">Candida albicans<\/jats:named-content>\n                    and\n                    <jats:named-content content-type=\"genus-species\">Candida glabrata<\/jats:named-content>\n                    , including azole- and echinocandin-resistant isolates. The objective of this analysis was to develop a population pharmacokinetic (PK) model to characterize the disposition of rezafungin in plasma following intravenous (i.v.) administration. Data from two phase 1 studies, a single-ascending-dose study and a multiple-ascending-dose study, were available. Candidate population PK models were fit to the pooled data using the Monte Carlo parametric expectation maximization algorithm in S-ADAPT. The data were best described using a linear four-compartment model with zero-order drug input via i.v. infusion and first-order elimination. In order to account for the relationships between the structural PK parameters and subject body weight, all parameters in the model were scaled to subject body weight using standard allometric coefficients (a power of 0.75 for the clearance terms and 1.0 for the volume terms). The final model fit the observed data with very little bias and excellent precision. The prediction-corrected visual predictive check demonstrated that the final model could accurately simulate both the central tendency and the variability of observed rezafungin plasma concentrations. Given this, the final rezafungin population PK model is expected to provide reliable simulated concentration-time profiles and can provide dose selection decision support for future clinical studies.\n                  <\/jats:p>","DOI":"10.1128\/aac.02603-17","type":"journal-article","created":{"date-parts":[[2018,3,19]],"date-time":"2018-03-19T05:57:36Z","timestamp":1521439056000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":37,"title":["Population Pharmacokinetic Analyses for Rezafungin (CD101) Efficacy Using Phase 1 Data"],"prefix":"10.1128","volume":"62","author":[{"given":"Elizabeth A.","family":"Lakota","sequence":"first","affiliation":[{"name":"Institute for Clinical Pharmacodynamics, Inc., Schenectady, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Voon","family":"Ong","sequence":"additional","affiliation":[{"name":"Cidara Therapeutics, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shawn","family":"Flanagan","sequence":"additional","affiliation":[{"name":"Cidara Therapeutics, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher M.","family":"Rubino","sequence":"additional","affiliation":[{"name":"Institute for Clinical Pharmacodynamics, Inc., Schenectady, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc1514201"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cub.2008.09.039"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.12.1.80"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cis697"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofv163"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.03255-14"},{"key":"e_1_3_2_8_2","article-title":"In vivo pharmacokinetic\/pharmacodynamic (PK\/PD) target characterization of the novel, long acting echinocandin CD101 against C. albicans and C. glabrata in the neutropenic murine disseminated candidiasis model","author":"Lepak AJ","year":"2017","unstructured":"Lepak AJ, Zhao M, VanScoy BA, Ambrose PG, Andes DR. 2017. In vivo pharmacokinetic\/pharmacodynamic (PK\/PD) target characterization of the novel, long acting echinocandin CD101 against C. albicans and C. glabrata in the neutropenic murine disseminated candidiasis model, abstr 1528. Abstr IDWeek.","journal-title":"abstr 1528"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02687-16"},{"key":"e_1_3_2_10_2","volume-title":"Eraxis\u00ae injection package insert","author":"Pfizer Inc","year":"2016","unstructured":"Pfizer Inc. 2016. Eraxis\u00ae injection package insert. Pfizer Inc., New York, NY. https:\/\/dailymed.nlm.nih.gov\/dailymed\/drugInfo.cfm?setid=a88d9010-55fb-4a02-baff-042cd27688ea. Accessed 22 February 2017."},{"key":"e_1_3_2_11_2","volume-title":"Cancidas\u00ae injection package insert","author":"Merck Sharp & Dohme","year":"2017","unstructured":"Merck Sharp & Dohme. 2017. Cancidas\u00ae injection package insert. Merck Sharp & Dohme, Kenilworth, NJ. https:\/\/dailymed.nlm.nih.gov\/dailymed\/drugInfo.cfm?setid=3bad23a6-09a6-4194-9182-093ed61bc71c. Accessed 22 February 2017."},{"key":"e_1_3_2_12_2","volume-title":"Mycamine\u00ae injection package insert","author":"Astellas Pharma US, Inc","year":"2016","unstructured":"Astellas Pharma US, Inc. 2016. Mycamine\u00ae injection package insert. Astellas Pharma US, Inc., Northbrook, IL. https:\/\/dailymed.nlm.nih.gov\/dailymed\/drugInfo.cfm?setid=bc234dd7-5221-4a68-b153-aa0393c75bbf. Accessed 22 February 2017."},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1002\/jps.2600751104"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1177\/0091270004265644"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01912-12"},{"key":"e_1_3_2_16_2","volume-title":"Abstr 48th Intersci Conf Antimicrob Agents Chemother","author":"Van Wart SA","year":"2008","unstructured":"Van Wart SA, Iyer V, Forrest A, Bhavnani SM, Ambrose PG, Andes DR. 2008. Population pharmacokinetics of micafungin in patients with invasive candidiasis, candidemia and esophageal candidiasis, abstr A-011. Abstr 48th Intersci Conf Antimicrob Agents Chemother. American Society for Microbiology, Washington, DC."},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.37.5.1065"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02033-13"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00176-15"},{"key":"e_1_3_2_20_2","volume-title":"Abstr 55th Intersci Conf Antimicrob Agents Chemother","author":"Hall D","year":"2015","unstructured":"Hall D, Shinabarger DL, Pillar CM. 2015. Evaluation of the fungicidal activity of CD101, a novel echinocandin, and comparators against recent clinical isolates of Candida spp., abstr M-825. Abstr 55th Intersci Conf Antimicrob Agents Chemother. American Society for Microbiology, Washington, DC."},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1086\/383320"},{"key":"e_1_3_2_22_2","volume-title":"Food and Drug Administration","author":"Food and Drug Administration, U.S. Department of Health and Human Services","year":"1999","unstructured":"Food and Drug Administration, U.S. Department of Health and Human Services. 1999. Guidance for industry: population pharmacokinetics. Food and Drug Administration, U.S. Department of Health and Human Services, Silver Spring, MD."},{"key":"e_1_3_2_23_2","volume-title":"Robert J","author":"Bauer RJ","year":"2006","unstructured":"Bauer RJ. 2006. S-ADAPT\/MCPEM. User's guide: software for pharmacokinetic, pharmacodynamic, and population data analysis. Robert J. Bauer, Berkeley, CA."},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/0010-468X(79)90025-4"},{"key":"e_1_3_2_25_2","volume-title":"ADAPT II user's guide: pharmacokinetic\/pharmacodynamic systems analysis software","author":"D'Argenio DZ","year":"2003","unstructured":"D'Argenio DZ, Schumitzky A. 2003. ADAPT II user's guide: pharmacokinetic\/pharmacodynamic systems analysis software. BMS Biomedical Simulations Resource, Los Angeles, CA."},{"key":"e_1_3_2_26_2","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/66.2.237"}],"updated-by":[{"DOI":"10.1128\/aac.00333-19","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2019,3,27]],"date-time":"2019-03-27T00:00:00Z","timestamp":1553644800000}}],"container-title":["Antimicrobial Agents and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.02603-17","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.02603-17","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,21]],"date-time":"2022-02-21T16:19:47Z","timestamp":1645460387000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/AAC.02603-17"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,6]]},"references-count":25,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2018,6]]}},"alternative-id":["10.1128\/AAC.02603-17"],"URL":"https:\/\/doi.org\/10.1128\/aac.02603-17","relation":{},"ISSN":["0066-4804","1098-6596"],"issn-type":[{"value":"0066-4804","type":"print"},{"value":"1098-6596","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,6]]},"assertion":[{"value":"2017-12-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-03-07","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-05-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e02603-17"}}