2021
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
2013
Dose Response and Pharmacokinetics of Tofacitinib (CP‐690,550), an Oral Janus Kinase Inhibitor, in the Treatment of Chronic Plaque Psoriasis
Tan H, Gupta P, Harness J, Wolk R, Chapel S, Menter A, Strober B, Langley R, Krishnaswami S, Papp K. Dose Response and Pharmacokinetics of Tofacitinib (CP‐690,550), an Oral Janus Kinase Inhibitor, in the Treatment of Chronic Plaque Psoriasis. CPT Pharmacometrics & Systems Pharmacology 2013, 2: 1-8. PMCID: PMC3674331, DOI: 10.1038/psp.2013.22.Peer-Reviewed Original ResearchBody weightPlacebo-controlled dose-ranging studyOral Janus kinase inhibitorPhase III clinical trialsPharmacokinetics of tofacitinibChronic plaque psoriasisDose-ranging studyPlaque psoriasis treatmentJanus kinase inhibitorNonlinear mixed-effects modelingTofacitinib 2Tofacitinib 5Confirmatory phase III clinical trialDose-response profilesPlaque psoriasisSystemic exposurePsoriasis treatmentSubgroup analysisMixed-effects modelingClinical trialsClinical dataTofacitinibPsoriasisKinase inhibitorsReduced efficacy
2012
Population Pharmacokinetics and Pharmacodynamics of Piperaquine in Children With Uncomplicated Falciparum Malaria
Tarning J, Zongo I, Somé FA, Rouamba N, Parikh S, Rosenthal PJ, Hanpithakpong W, Jongrak N, Day NP, White NJ, Nosten F, Ouedraogo J, Lindegardh N. Population Pharmacokinetics and Pharmacodynamics of Piperaquine in Children With Uncomplicated Falciparum Malaria. Clinical Pharmacology & Therapeutics 2012, 91: 497-505. PMID: 22258469, PMCID: PMC3736305, DOI: 10.1038/clpt.2011.254.Peer-Reviewed Original ResearchConceptsUncomplicated falciparum malariaFalciparum malariaPopulation pharmacokineticsThree-compartment distribution modelNonlinear mixed-effects modelingRecurrent malaria infectionsTotal piperaquine exposureArtemisinin combination treatmentWeight-normalized dosePlasma concentration-time profilesYoung childrenMixed-effects modelingConcentration-time profilesPiperaquine concentrationsPiperaquine exposureDose regimenMalaria infectionPlasma concentrationsPharmacodynamic propertiesCombination treatmentBody weightPiperaquineSignificant covariatesOlder childrenMalaria
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