2024
Pilot PET study of vaginally administered bioadhesive nanoparticles in cynomolgus monkeys: Kinetics and safety evaluation
Grun M, Honhar P, Wang Y, Rossano S, Khang M, Suh H, Fowles K, Kliman H, Cavaliere A, Carson R, Marquez‐Nostra B, Saltzman W. Pilot PET study of vaginally administered bioadhesive nanoparticles in cynomolgus monkeys: Kinetics and safety evaluation. Bioengineering & Translational Medicine 2024, 9: e10661. PMID: 39553429, PMCID: PMC11561825, DOI: 10.1002/btm2.10661.Peer-Reviewed Original ResearchVaginal dosage formsBioadhesive nanoparticlesCynomolgus monkeysAnalysis of inflammatory biomarkersVaginal microbicidesVaginal canalMultiple dosesInflammatory biomarkersTherapeutic efficacyVaginal fluidSystemic circulationLong-term deliveryNoninvasive imagingClinical translationDosage formsNon-human primatesDelivery vehiclesMonkeysDeliveryVaginitisUterusMicrobicidesSafety evaluationBiodistributionDose
2021
Safety Evaluation of the Second Dose of Messenger RNA COVID-19 Vaccines in Patients With Immediate Reactions to the First Dose
Krantz MS, Kwah JH, Stone CA, Phillips EJ, Ortega G, Banerji A, Blumenthal KG. Safety Evaluation of the Second Dose of Messenger RNA COVID-19 Vaccines in Patients With Immediate Reactions to the First Dose. JAMA Internal Medicine 2021, 181: 1530-1533. PMID: 34309623, PMCID: PMC8314170, DOI: 10.1001/jamainternmed.2021.3779.Peer-Reviewed Original Research
2020
The potential danger of suboptimal antibody responses in COVID-19
Iwasaki A, Yang Y. The potential danger of suboptimal antibody responses in COVID-19. Nature Reviews Immunology 2020, 20: 339-341. PMID: 32317716, PMCID: PMC7187142, DOI: 10.1038/s41577-020-0321-6.Peer-Reviewed Original Research
2019
Double-Robust Estimation in Difference-in-Differences with an Application to Traffic Safety Evaluation
Li F, Li F. Double-Robust Estimation in Difference-in-Differences with an Application to Traffic Safety Evaluation. Observational Studies 2019, 5: 1-23. DOI: 10.1353/obs.2019.0009.Peer-Reviewed Original Research
2015
Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study
Zeitoun JD, Lefèvre JH, Downing NS, Bergeron H, Ross JS. Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study. Pharmacoepidemiology And Drug Safety 2015, 25: 687-694. PMID: 26554874, DOI: 10.1002/pds.3910.Peer-Reviewed Original ResearchConceptsDear Healthcare Professional CommunicationsEuropean Medicines AgencySafety eventsSafety concernsHealthcare Professional CommunicationsNovel medicinesCentralized authorization procedureEMA websitePostmarket studiesRegulatory reviewPostmarket periodMedicines AgencyWithdrawalSafety communicationMedicineSafety evaluationReview
2005
Preliminary phase II safety evaluation of ZD6474, in combination with carboplatin and paclitaxel, as 1 st -line treatment in patients with NSCLC
Johnson B, Ma P, West H, Kerr R, Prager D, Sandler A, Herbst R, Stewart D, Dimery I, Heymach J. Preliminary phase II safety evaluation of ZD6474, in combination with carboplatin and paclitaxel, as 1 st -line treatment in patients with NSCLC. Journal Of Clinical Oncology 2005, 23: 7102-7102. DOI: 10.1200/jco.2005.23.16_suppl.7102.Peer-Reviewed Original Research
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