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Population Pharmacokinetic Analyses for Rezafungin (CD101) Efficacy Using Phase 1 Data.


ABSTRACT: Rezafungin (CD101) is a novel echinocandin antifungal agent currently in clinical development for the treatment of candidemia and invasive candidiasis. Rezafungin has potent in vitro activity against Candida albicans and Candida glabrata, 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 fo

SUBMITTER: Lakota EA 

PROVIDER: S-EPMC5971566 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature