2024
Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence
Mooghali M, Zhou T, Ross J. Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence. BMJ Open 2024, 14: e090376. PMID: 39461853, PMCID: PMC11529451, DOI: 10.1136/bmjopen-2024-090376.Peer-Reviewed Original ResearchConceptsPhase 2 trialPhase 3 trialBox warningAtrial fibrillation patientsPostmarketing evidenceEvidence of safetyOral anticoagulantsFibrillation patientsPostmarketing studiesCross-sectional analysisDegree of concordanceStroke preventionStudy requirementsPostmarketingEfficacy evidenceRegulatory agenciesDrugPostmarketing requirementsInterpretation of resultsEfficacyHealth CanadaSample sizeSafety evidenceConcordanceEndpointScaleable production of highly loaded protein nanoparticles for immune modulation
Caplan M, Baldwin R, Yin X, Grishin A, Eisenbarth S, Sampson H, Bottomly K, Prud’homme R. Scaleable production of highly loaded protein nanoparticles for immune modulation. Communications Materials 2024, 5: 191. DOI: 10.1038/s43246-024-00626-w.Peer-Reviewed Original ResearchAdjuvants to antigen-presenting cellsImmune modulationAntigen-presenting cellsMurine immune systemImmune system cellsPeanut-allergic patientsDesensitizer applicationPLG nanoparticlesAntigen deliverySystemic exposurePoly(lactide-co-glycolideBasophil activationClinical investigationAllergic responsesImmune systemSystem cellsProtein antigensClinical applicationDelivery of proteinsE. coli phospholipidsSafety evidenceAntigenProtein nanoparticlesDeliveryCells
2017
Safety and benefit considerations for menopausal hormone therapy
Pickar JH, Archer DF, Kagan R, Pinkerton JV, Taylor HS. Safety and benefit considerations for menopausal hormone therapy. Expert Opinion On Drug Safety 2017, 16: 941-954. PMID: 28664754, DOI: 10.1080/14740338.2017.1343298.Peer-Reviewed Original ResearchConceptsSafety of HTConjugated equine estrogensHormone therapyEquine estrogensHealth initiativesDifferent estrogensEstrogen-progestogen therapyMenopausal hormone therapyUnexpected safety concernsWomen's Health InitiativeRoute of administrationHT initiationEffect of ageSafety profileDifferent progestogensCardiovascular diseaseObservational studySynthetic progestinsAdministration routeEstrogenTherapyClinical useSafety evidenceRegimensFurther studies
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