2021
Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy
Grada A, Del Rosso JQ, Graber E, Bunick CG, Gold L, Moore AY, Baldwin H, Obagi Z, Damiani G, Carrothers T, McNamee B, Hanze E. Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy. Dermatologic Therapy 2021, 35: e15275. PMID: 34923732, PMCID: PMC9286649, DOI: 10.1111/dth.15275.Peer-Reviewed Original ResearchConceptsTetracycline-class antibioticsWeight-based dosingHigh-fat mealClinical efficacyAcne vulgarisFood intakeWeight-based dosing protocolAcne vulgaris patientsLow clinical efficacyExposure-response modelingPopulation pharmacokinetic modelingAcne vulgaris treatmentHigh-fat foodsDosing protocolDosing recommendationsInflammatory lesionsVulgaris patientsExtent of exposureClinical studiesImproved complianceGastrointestinal absorptionVulgaris treatmentDrug AdministrationPharmacokinetic modelingEfficacy
2015
Dose Selection of Antithrombin (Recombinant) for a Phase 3 Trial in Early-Onset Preeclampsia [149]
Paidas M, Frieling J, de Jongh J, Drenth H, Streisand J. Dose Selection of Antithrombin (Recombinant) for a Phase 3 Trial in Early-Onset Preeclampsia [149]. Obstetrics And Gynecology 2015, 125: 52s. DOI: 10.1097/01.aog.0000463689.71574.8f.Peer-Reviewed Original ResearchEarly-onset preeclampsiaRecombinant human antithrombinPhase 3 trialPopulation pharmacokinetic modelingHuman antithrombinAntithrombin deficiencyPlasma antithrombinPharmacokinetic modelingHereditary antithrombin deficiencyPopulation pharmacokinetic modelAntithrombin activity levelsDifferent pharmacokinetic propertiesPrior human studiesExpectant managementPerinatal morbidityPregnant patientsLoading doseMaternal administrationPregnant womenContinuous infusionSimilar efficacyClinical studiesPleiotropic effectsAntithrombin treatmentDose selection
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