Population Pharmacokinetics and Exposure‐Response Modeling of Daratumumab Subcutaneous Administration in Patients With Light‐Chain Amyloidosis
Luo M, Zhu P, Nnane I, Xiong Y, Merlini G, Comenzo R, Kastritis E, Wechalekar A, Weiss B, Tran N, Qin X, Vermeulen J, Sharma A, Sun Y, Zhou H. Population Pharmacokinetics and Exposure‐Response Modeling of Daratumumab Subcutaneous Administration in Patients With Light‐Chain Amyloidosis. The Journal Of Clinical Pharmacology 2021, 62: 656-669. PMID: 34708423, DOI: 10.1002/jcph.1994.Peer-Reviewed Original ResearchConceptsLight chain amyloidosisSafety end pointSystemic exposureExposure-response analysesEnd pointsPopulation pharmacokineticsAmyloid light-chain amyloidosisNo dose adjustmentEfficacy end pointSystemic amyloid light-chain amyloidosisExposure-responseTreatment of light-chain amyloidosisImpact of potential covariatesLogistic regression analysisNonlinear mixed-effects modelingConcentration-time dataDexamethasone regimenDose adjustmentHematologic responseDaratumumabImmunogenicity dataPopPK analysisPopPK model
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