2016
Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke
Lees K, Khatri P, Alexandrov A, Bivard A, Boltze J, Broderick J, Campbell B, Creighton F, Fiorella D, Furlan A, Gorelick P, Hess D, Kim W, Latour L, Liebeskind D, Luby M, Lyden P, Lynch J, Marshall R, Menon B, Muir K, Palesch Y, Peng H, Pryor K, Mocco J, Rasmussen P, Sacco R, Schwamm L, Smith E, Solberg Y, Vagal A, Warach S, Wechsler L, Wintermark M, Yoo A, Zander K. Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke. Stroke 2016, 47: 2154-2159. PMID: 27406108, PMCID: PMC4961517, DOI: 10.1161/strokeaha.116.012966.Peer-Reviewed Original ResearchConceptsPooled analysisClinical implicationsClinical trial findingsIndividual patient dataPooled findingsPrespecified subgroupsOngoing trialsStroke trialsTrial findingsTreatment strategiesClinical careIndividual drugsPooling analysisTrial teamSuch drugsClass effectSevere disabilityTrial resultsPatient dataAnalysis planTrialsStatistical adjustmentTreatment effects
2012
Rapid Evaluation in Whole Blood Culture of Regimens for XDR-TB Containing PNU-100480 (Sutezolid), TMC207, PA-824, SQ109, and Pyrazinamide
Wallis RS, Jakubiec W, Mitton-Fry M, Ladutko L, Campbell S, Paige D, Silvia A, Miller PF. Rapid Evaluation in Whole Blood Culture of Regimens for XDR-TB Containing PNU-100480 (Sutezolid), TMC207, PA-824, SQ109, and Pyrazinamide. PLOS ONE 2012, 7: e30479. PMID: 22279595, PMCID: PMC3261206, DOI: 10.1371/journal.pone.0030479.Peer-Reviewed Original ResearchMeSH KeywordsAdamantaneAntitubercular AgentsDiarylquinolinesDrug MonitoringDrug Therapy, CombinationEthylenediaminesExtensively Drug-Resistant TuberculosisHumansMicrobial Sensitivity TestsMycobacterium tuberculosisNitroimidazolesOxazolidinonesPyrazinamideQuinolinesReproducibility of ResultsTime FactorsConceptsPNU-100480Whole blood culturesPA-824Blood culturesWhole-blood bactericidal activityBactericidal activityStandard TB therapyDihydroxy vitamin DIntracellular M. tuberculosisBlood bactericidal activityCumulative activityPZA-resistant strainsHigh therapeutic concentrationsActive regimensTB regimensNew regimensTB therapyVitamin DOral dosingTherapeutic concentrationsDrug combinationsPharmacokinetic dataRegimensIndividual drugsTMC207SQ109 and PNU-100480 interact to kill Mycobacterium tuberculosis in vitro
Reddy VM, Dubuisson T, Einck L, Wallis RS, Jakubiec W, Ladukto L, Campbell S, Nacy CA. SQ109 and PNU-100480 interact to kill Mycobacterium tuberculosis in vitro. Journal Of Antimicrobial Chemotherapy 2012, 67: 1163-1166. PMID: 22258923, DOI: 10.1093/jac/dkr589.Peer-Reviewed Original ResearchConceptsPNU-100480Whole blood culturesMycobacterium tuberculosisRate of killingBlood culturesOrder of efficacyChequerboard titrationIndividual drugsIntracellular M. tuberculosisIntracellular Mycobacterium tuberculosisTime-kill studiesTwo-drug interactionsIntracellular activityMtb killingJ774A.1 mouse macrophagesSQ109M. tuberculosisMajor metaboliteTuberculosisMouse macrophagesBactericidal activityDrugsEfficacyKillingMacrophages
1981
Animal toxicology for early clinical trials with anticancer agents.
Rozencweig M, Von Hoff D, Staquet M, Schein P, Penta J, Goldin A, Muggia F, Freireich E, DeVita V. Animal toxicology for early clinical trials with anticancer agents. American Journal Of Clinical Oncology 1981, 4: 21-8. PMID: 6783332.Peer-Reviewed Original ResearchConceptsPhase I clinical trialEarly clinical trialsClinical trialsOrgan system toxicityStarting doseSystem toxicityChemotherapeutic agentsDose-escalation stepsCommon toxic effectsGastrointestinal intoleranceInitial doseClinical dataEscalation stepsAnimal findingsToxic doseToxic manifestationsIndividual drugsPredictive valueAnimal toxicologyMiceDoseIdentical scheduleLD10Acceptable dosesDogs
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