2020
Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies
Falchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clinical Cancer Research 2020, 26: 1247-1257. PMID: 31527168, PMCID: PMC7528620, DOI: 10.1158/1078-0432.ccr-18-4071.Peer-Reviewed Original ResearchConceptsAdvanced malignanciesGrade treatment-related adverse eventsTreatment-related adverse eventsAdequate organ functionHigh interpatient variabilityFavorable PK profileOptimal dosing schemePrimary endpointAdverse eventsOral clearancePartial responseComplete responsePhase 1/2Terminal eliminationTolerability studyPatient populationPharmacodynamic profileInterpatient variabilityDosing schemesDistinct pharmacokineticsTherapeutic indexOrgan functionPK profilesExtraterminal (BET) inhibitorsTarget inhibition
2012
Clinical pharmacokinetics of the Smac-mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens.
Fetterly G, Liu B, Senzer N, Amaravadi R, Schilder R, Martin L, LoRusso P, Papadopoulos K, Adjei A, Zagst P, McKinlay M, Weng D, Graham M. Clinical pharmacokinetics of the Smac-mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens. Journal Of Clinical Oncology 2012, 30: 3029-3029. DOI: 10.1200/jco.2012.30.15_suppl.3029.Peer-Reviewed Original ResearchPaclitaxel/carboplatinMultiple chemotherapy regimensChemotherapy regimensWeekly dosingInterpatient variabilityLiposomal doxorubicinPK modelDose-proportional kineticsModerate interpatient variabilityPopulation PK modelPopulation PK modelingSMAC mimetic birinapantBlockade of apoptosisAdvanced malignanciesCombination regimensConcomitant administration
2005
Population Pharmacokinetics of Delavirdine and N-Delavirdine in HIV-Infected Individuals
Smith PF, DiCenzo R, Forrest A, Shelton M, Friedland G, Para M, Pollard R, Fischi M, DiFrancesco R, Morse GD. Population Pharmacokinetics of Delavirdine and N-Delavirdine in HIV-Infected Individuals. Clinical Pharmacokinetics 2005, 44: 99-109. PMID: 15634033, DOI: 10.2165/00003088-200544010-00004.Peer-Reviewed Original ResearchConceptsLarge interpatient variabilityPharmacokinetic parameter estimatesCombination regimensPopulation pharmacokineticsInterpatient variabilityNon-nucleoside reverse transcriptase inhibitorPopulation pharmacokinetic parameter estimatesCells/mm3Double-blind studyHIV-1 infectionMean apparent volumeAge 37 yearsPopulation pharmacokinetic analysisReverse transcriptase inhibitorVolume of distributionFirst-order clearanceTherapeutic drug monitoringTarget drug concentrationsCD4 countMonotherapy studiesOral clearanceDosage regimensPlasma concentrationsTranscriptase inhibitorPharmacokinetic analysis
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