2025
Outcomes of Outpatient Advanced Therapy Exposed Patients Hospitalized With Severe Ulcerative Colitis
Al-Bawardy B, Al Sulais E, AlHarthi F, Mohamed G, Mukhtar M, Hart A, Raine T. Outcomes of Outpatient Advanced Therapy Exposed Patients Hospitalized With Severe Ulcerative Colitis. Crohn's & Colitis 360 2025, 7: otaf055. PMID: 40979857, PMCID: PMC12448430, DOI: 10.1093/crocol/otaf055.Peer-Reviewed Original ResearchRisk of colectomyRescue medical therapyLow albuminUlcerative colitisSevere UCColectomy rateDrug exposureMedical therapyRetrospective studyDisease severityAdvanced therapiesATE groupMultivariate analysisRetrospective study of adult patientsStudy of adult patientsHigh C-reactive proteinHigher colectomy rateMedian hospital lengthSevere ulcerative colitisCharacteristics of hospitalized patientsAssociated with colectomyC-reactive proteinLength of hospitalizationMeasures of disease severityLength of staySubstance Misuse, Executive Function, and Young Adult Intimate Partner Violence: Direct and Indirect Pathways.
Martin E, Ramos K, Modanesi E, Mayes L, Stover C. Substance Misuse, Executive Function, and Young Adult Intimate Partner Violence: Direct and Indirect Pathways. Journal Of Interpersonal Violence 2025, 8862605251326641. PMID: 40123291, DOI: 10.1177/08862605251326641.Peer-Reviewed Original ResearchIntimate partner violence riskIntimate partner violenceEarly adolescent substance usePrenatal drug exposureAdolescent substance useExecutive functionSubstance useMaternal educationAdult intimate partner violencePredicting intimate partner violencePrevent intimate partner violenceHigh-risk subjectsYoung adult relationshipsContribution of childhood maltreatmentDevelopmental trajectories of individualsAdolescents' executive functionLow maternal educationWell-being consequencesEnhance executive functionLongitudinal birth cohortYoung adultsDrug exposureIPV riskPartner violenceSex-specific effects
2024
Hepatotoxicity Score: A New Method to Adjust for Use of Potentially Hepatotoxic Medications by Chronic Liver Disease Status
Re V, Newcomb C, Carbonari D, Mezochow A, Hennessy S, Rentsch C, Park L, Tate J, Bräu N, Bhattacharya D, Lim J, Mezzacappa C, Njei B, Roy J, Taddei T, Justice A, Torgersen J. Hepatotoxicity Score: A New Method to Adjust for Use of Potentially Hepatotoxic Medications by Chronic Liver Disease Status. Pharmacoepidemiology And Drug Safety 2024, 33: e70069. PMID: 39662972, PMCID: PMC11634562, DOI: 10.1002/pds.70069.Peer-Reviewed Original ResearchConceptsProton pump inhibitor initiationHazard ratioVeterans Health AdministrationSevere acute liver injuryProton pump inhibitorsChronic liver diseaseAcute liver injuryRates of hospitalizationSafety of medicationsPPI initiativesHealth AdministrationLiver disease statusMedication exposurePharmacoepidemiological studiesMedicationConfoundingScoresReports of hepatotoxicityDisease statusHepatotoxic medicationsDrug exposurePump inhibitorsHepatotoxic drugsOutpatient initiationHepatic safetyFetal behavior and gestational serotonin reuptake inhibitor exposure: relationships between behavior, drug dosage, plasma drug level, and a measure of drug bioeffect
Salisbury A, Anderson G, Yang A, Stika C, Rasmussen-Torvik L, Gollan J, Wisner K. Fetal behavior and gestational serotonin reuptake inhibitor exposure: relationships between behavior, drug dosage, plasma drug level, and a measure of drug bioeffect. Neuropsychopharmacology 2024, 49: 1968-1977. PMID: 39127823, PMCID: PMC11480508, DOI: 10.1038/s41386-024-01923-1.Peer-Reviewed Original ResearchConceptsPlatelet 5-HT levelsSerotonin reuptake inhibitorsPlasma drug concentrationsDEP groupPresence of maternal depressionSerotonin reuptake inhibitor exposureDrug exposureSRI groupDrug dosageMeasure of drug exposureDrug concentrationsPlasma drug levelsMother-infant pairsGroups of mother-infant pairsReuptake inhibitorsMaternal depressionFetal behaviorCord bloodFetal movementsPlatelet serotoninDrug levelsInhibitor exposureDepressionSerotoninCordPhase 1, first-in-human study of TYRP1-TCB (RO7293583), a novel TYRP1-targeting CD3 T-cell engager, in metastatic melanoma: active drug monitoring to assess the impact of immune response on drug exposure
Spreafico A, Couselo E, Irmisch A, Bessa J, Au-Yeung G, Bechter O, Svane I, Sanmamed M, Gambardella V, McKean M, Callahan M, Dummer R, Klein C, Umaña P, Justies N, Heil F, Fahrni L, Opolka-Hoffmann E, Waldhauer I, Bleul C, Staack R, Karanikas V, Fowler S. Phase 1, first-in-human study of TYRP1-TCB (RO7293583), a novel TYRP1-targeting CD3 T-cell engager, in metastatic melanoma: active drug monitoring to assess the impact of immune response on drug exposure. Frontiers In Oncology 2024, 14: 1346502. PMID: 38577337, PMCID: PMC10991832, DOI: 10.3389/fonc.2024.1346502.Peer-Reviewed Original ResearchTreatment-related adverse eventsAnti-drug antibodiesCytokine release syndromeFirst-in-humanT-cell engagersCheckpoint inhibitorsMetastatic melanomaT cellsDrug exposureDevelopment of anti-drug antibodiesActive drugImmune responseFirst-in-human studyDrug activity in vitroDose-escalation studyDose-escalation trialTumor necrosis factor-alphaB cell interactionsImpact of immune responsesActive drug exposureNecrosis factor-alphaAnti-tumor activityLoss of efficacyAssociated with developmentDose escalation
2023
Stable Isotope Labelling Kinetics: Models and methods to evaluate APP production rates with Posiphen treatment in the DISCOVER clinical trial
Elbert D, Galasko D, Farlow M, Aslanyan V, Pa J, Lucey B, Honig L, Moghekar A, Bateman R, Momper J, Rissman R, Balasubramanian A, Maccecchini M, Feldman H, Group A. Stable Isotope Labelling Kinetics: Models and methods to evaluate APP production rates with Posiphen treatment in the DISCOVER clinical trial. Alzheimer's & Dementia 2023, 19 DOI: 10.1002/alz.077287.Peer-Reviewed Original ResearchAβ40 concentrationsBeta-amyloid precursor protein (APP) mRNAAmyloid precursor protein (APP) mRNASequential dose cohortsHigh-dose groupMild AD dementiaPrecursor protein mRNADose cohortsVenous cathetersStudy armsAD dementiaDose groupDrug exposureVenous bloodPosiphenAβ kineticsDay 22Therapeutic potentialPlaceboDecreased productionGroup differencesPatientsPharmacodynamicsFurther clarificationHoursAntithyroid drug exposure during 1,191,904 pregnancies in denmark: a 20-year longitudinal study before and after implementation of iodine fortification
Maria U, Liew Z, Carle A, Scott K, Bulow P, Andersen S, Linding A. Antithyroid drug exposure during 1,191,904 pregnancies in denmark: a 20-year longitudinal study before and after implementation of iodine fortification. Endocrine Abstracts 2023 DOI: 10.1530/endoabs.92.op-06-01.Peer-Reviewed Original ResearchDrug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms. Part I. Epidemiology, pathogenesis, clinicopathological features, and prognosis
Wei B, Fox L, Kaffenberger B, Korman A, Micheletti R, Mostaghimi A, Noe M, Rosenbach M, Shinkai K, Kwah J, Phillips E, Bolognia J, Damsky W, Nelson C. Drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms. Part I. Epidemiology, pathogenesis, clinicopathological features, and prognosis. Journal Of The American Academy Of Dermatology 2023, 90: 885-908. PMID: 37516359, DOI: 10.1016/j.jaad.2023.02.072.Peer-Reviewed Original ResearchSevere cutaneous adverse reactionsDiHS/DRESSClinicopathological featuresSystemic symptomsDrug reactionsDrug-induced hypersensitivity syndrome/drug reactionDrug-induced hypersensitivity syndromePart I. EpidemiologyVisceral organ involvementCutaneous adverse reactionsRisk of relapseHypersensitivity syndromeOrgan involvementI. EpidemiologyOrgan dysfunctionSignificant morbidityAutoimmune diseasesAdverse reactionsDrug exposureT cellsCommon triggerImmune systemPathogenesisEosinophiliaMedical education activitiesBaseline platelet serotonin in a multi-site treatment study of depression in veterans administration patients: Distribution and effects of demographic variables and serotonin reuptake inhibitors
Anderson G, Ramsey C, Lynch K, Gelernter J, Oslin D. Baseline platelet serotonin in a multi-site treatment study of depression in veterans administration patients: Distribution and effects of demographic variables and serotonin reuptake inhibitors. Journal Of Affective Disorders 2023, 327: 368-377. PMID: 36754092, DOI: 10.1016/j.jad.2023.02.017.Peer-Reviewed Original ResearchConceptsReuptake inhibitorsVeterans Administration patientsTreatment studiesSubset of patientsNorepinephrine reuptake inhibitorsCross-sectional studyEffect of ageDose adjustmentAfrican American individualsDemographic variablesMean plateletDrug exposurePlatelet serotoninSerotonin valuesPatientsClinical implicationsHealth recordsMale groupSSRIsDepressionPlateletsEuropean AmericansInhibitorsSex differencesGroup meansChapter 11 Cholinergic modulation of circuits
Addy N, Fowler C, Wickham R. Chapter 11 Cholinergic modulation of circuits. 2023, 409-444. DOI: 10.1016/b978-0-12-823453-2.00004-7.Chapters
2022
Impact of Drug Exposure on Resistance Selection Following Artemether‐Lumefantrine Treatment for Malaria in Children With and Without HIV in Uganda
Kay K, Goodwin J, Ehrlich H, Ou J, Freeman T, Wang K, Li F, Wade M, French J, Huang L, Aweeka F, Mwebaza N, Kajubi R, Riggs M, Ruiz‐Garcia A, Parikh S. Impact of Drug Exposure on Resistance Selection Following Artemether‐Lumefantrine Treatment for Malaria in Children With and Without HIV in Uganda. Clinical Pharmacology & Therapeutics 2022, 113: 660-669. PMID: 36260349, PMCID: PMC9981240, DOI: 10.1002/cpt.2768.Peer-Reviewed Original ResearchConceptsLopinavir-ritonavirLumefantrine concentrationsSensitive parasitesRecurrence riskPopulation PK/PD modelArtemether-lumefantrine treatmentTrimethoprim-sulfamethoxazole prophylaxisPK/PD modelPopulation PK modelFirst-order absorptionHigh transmission regionsAntiretroviral regimensLumefantrine exposureLumefantrine susceptibilityPfcrt K76Pfmdr1 N86Suboptimal dosingArtemether-lumefantrineTwo-compartment modelHIV statusRecurrent infectionsCombination therapyDrug exposurePrimary treatmentArtemisinin resistanceThe Impact of Extended Treatment With Artemether-lumefantrine on Antimalarial Exposure and Reinfection Risks in Ugandan Children With Uncomplicated Malaria: A Randomized Controlled Trial
Whalen ME, Kajubi R, Goodwin J, Orukan F, Colt M, Huang L, Richards K, Wang K, Li F, Mwebaza N, Aweeka FT, Parikh S. The Impact of Extended Treatment With Artemether-lumefantrine on Antimalarial Exposure and Reinfection Risks in Ugandan Children With Uncomplicated Malaria: A Randomized Controlled Trial. Clinical Infectious Diseases 2022, 76: 443-452. PMID: 36130191, PMCID: PMC9907485, DOI: 10.1093/cid/ciac783.Peer-Reviewed Original ResearchConceptsArtemether-lumefantrineReinfection riskArtemisinin-based combination therapyDay 7 levelsOverall drug exposureHigh transmission settingsYoung childrenAntimalarial exposureUncomplicated malariaExtended regimenRecurrent parasitemiaControlled TrialsPrimary outcomeCombination therapyKaplan-MeierDrug exposureTotal episodesUgandan childrenArtemisinin resistanceLumefantrine concentrationsPharmacodynamic studiesHigh riskPharmacokinetic parametersRecurrence riskDay 7Pharmacokinetics and Tolerability of Intraperitoneal Chloroprocaine After Fetal Extraction in Women Undergoing Cesarean Delivery
Togioka BM, Zarnegarnia Y, Bleyle LA, Koop D, Brookfield K, Yanez ND, Treggiari MM. Pharmacokinetics and Tolerability of Intraperitoneal Chloroprocaine After Fetal Extraction in Women Undergoing Cesarean Delivery. Anesthesia & Analgesia 2022, 135: 777-786. PMID: 35544759, DOI: 10.1213/ane.0000000000006064.Peer-Reviewed Original ResearchConceptsLocal anesthetic systemic toxicityPeak plasma concentrationCesarean deliveryPlasma concentrationsSystemic toxicityIntraperitoneal administrationFetal extractionMultiple-dose escalation studyPatient drug exposureMaternal blood samplesMaximum plasma concentrationRoute of administrationYears of ageClinical tolerabilityEscalation studySpinal anesthesiaUterine closureNeuraxial anesthesiaClinical symptomsDrug exposureClinical signsWomen 18Prospective assessmentBlood samplesPharmacokinetic profile
2021
Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Arrieta AC, Neely M, Day JC, Rheingold SR, Sue PK, Muller WJ, Danziger-Isakov LA, Chu J, Yildirim I, McComsey GA, Frangoul HA, Chen TK, Statler VA, Steinbach WJ, Yin DE, Hamed K, Jones ME, Lademacher C, Desai A, Micklus K, Phillips DL, Kovanda LL, Walsh TJ. Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients. Antimicrobial Agents And Chemotherapy 2021, 65: 10.1128/aac.00290-21. PMID: 34031051, PMCID: PMC8284446, DOI: 10.1128/aac.00290-21.Peer-Reviewed Original ResearchConceptsPhase 1 studyPediatric patientsIsavuconazonium sulfatePlasma drug exposureDrug exposureOral administrationImmunocompromised Pediatric PatientsNew triazole agentProdrug isavuconazonium sulfateTolerability of isavuconazoleBody mass indexPopulation PK modelInvasive fungal infectionsProbability of targetTarget rangeConcentration-time curveFirst-order inputMass indexPopulation pharmacokineticsStepwise covariate modelingTriazole agentsClinical dosePK parametersLinear eliminationPatientsLongitudinal Effects of Acute Cannabis Exposure on Automobile Driving Behavior in a Naturalistic Simulated Environment
Meda S, Boer E, Ward N, Book G, Stevens M, Boyle C, Mubeen M, Pearlson G. Longitudinal Effects of Acute Cannabis Exposure on Automobile Driving Behavior in a Naturalistic Simulated Environment. 2021 DOI: 10.26828/cannabis.2021.01.000.21.Peer-Reviewed Original ResearchAcute cannabis exposureHigh-dose subjectsDrug dose levelsSignificant public health riskCannabis exposureDose studyDrug exposureSimulated environmentInfluence of cannabisSafe overtakingSingle acuteHigh doseSPSS v24Psychomotor functionComplex dayDriving functionsDose levelsHigh dosesSeparate daysPublic health riskOverall riskIntoxicated subjectsDoseThree timesNumerous metricsChapter 48 Malignancies in systemic lupus erythematosus
Ladouceur A, Tissera H, Clarke A, Ramsey-Goldman R, Gordon C, Hansen J, Bernatsky S. Chapter 48 Malignancies in systemic lupus erythematosus. 2021, 461-467. DOI: 10.1016/b978-0-12-814551-7.00048-9.ChaptersSystemic lupus erythematosusSLE patientsLupus erythematosusGeneral populationOverall cancer incidence ratesHormone-sensitive cancersCancer incidence ratesRisk of breastDrug exposureIncidence rateProstate cancerHormonal changesHigh riskCancer profilePatientsCancerGenetic factorsErythematosusRiskPotential reasonsLymphomaMalignancyPathophysiologyPopulationBreast
2020
Social and legal implications of urine drug screen analysis in the neonate: A case of suspected specimen mishandling
Puthenpura V, Gueye-Ndiaye S, Joshi S, Puvabanditsin S, Carayannopoulos M. Social and legal implications of urine drug screen analysis in the neonate: A case of suspected specimen mishandling. Clinica Chimica Acta 2020, 511: 104-106. PMID: 33002470, DOI: 10.1016/j.cca.2020.09.032.Peer-Reviewed Original ResearchElectrocardiographic QT Intervals in Infants Exposed to Hydroxychloroquine Throughout Gestation
Friedman DM, Kim M, Costedoat-Chalumeau N, Clancy R, Copel J, Phoon CK, Cuneo B, Cohen R, Masson M, Wainwright BJ, Zahr N, Saxena A, Izmirly P, Buyon JP. Electrocardiographic QT Intervals in Infants Exposed to Hydroxychloroquine Throughout Gestation. Circulation Arrhythmia And Electrophysiology 2020, 13: e008686. PMID: 32907357, PMCID: PMC7668319, DOI: 10.1161/circep.120.008686.Peer-Reviewed Original ResearchMeSH KeywordsAntiviral AgentsCardiotoxicityDrug Administration ScheduleDrug MonitoringElectrocardiographyFemaleFetal BloodFetal HeartGestational AgeHeart BlockHeart RateHumansHydroxychloroquineInfantInfant, NewbornMalePredictive Value of TestsPregnancyRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeConceptsBlood levelsSSA/Ro antibodiesHistorical healthy controlsHydroxychloroquine blood levelsCord blood levelsCongenital heart blockSystemic lupus erythematosusTrimester of pregnancyEfficacy of hydroxychloroquineCoronavirus disease-19Electrocardiographic QT intervalCOVID-19 studiesPostnatal ECGRo antibodiesIndividual pregnanciesLupus erythematosusQTc prolongationAntiviral therapyHeart blockClinical efficacyRheumatic conditionsDrug exposureMaternal useCord bloodDisease-19Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies.
Hamilton E, Patel M, Rodon J, Hong D, Schram A, Janne P, LoRusso P, Sachdev J, Ou S, Buck E, O'Connor M, Waters N, Witt K, Cook C. Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies. Journal Of Clinical Oncology 2020, 38: tps3665-tps3665. DOI: 10.1200/jco.2020.38.15_suppl.tps3665.Peer-Reviewed Original ResearchAntitumor activityStandard therapyPreliminary efficacyERBB mutationsOpen-label multicenter studySignificant unmet need existsPhase I/IIHER2 tyrosine kinase inhibitorPhase 2 doseAdvanced solid malignanciesAdequate drug exposureMetastatic solid tumorsPreliminary antitumor activityExon 20 insertionsOncogenic driver mutationsTyrosine kinase inhibitorsUnmet need existsAssessment of safetyCurrent eGFRExpansion cohortMulticenter studyPharmacodynamic effectsSolid malignanciesDrug exposureCohort 1
2019
Acute Cannabis Toxicity.
Wong KU, Baum CR. Acute Cannabis Toxicity. Pediatric Emergency Care 2019, 35: 799-804. PMID: 31688799, DOI: 10.1097/pec.0000000000001970.Peer-Reviewed Original ResearchConceptsPoison control center callsEmergency department visitsPublic health implicationsPediatric toxicityCannabis-containing productsRespiratory depressionDepartment visitsPediatric patientsCannabis exposureDrug exposureUnintentional ingestionCannabis intoxicationCannabis useHealth implicationsCenter callsCannabisMedicinal useExposurePatientsCliniciansIntoxicationVisitsIngestion
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