A5048107649- Cardiac electrophysiology and arrhythmias
- Atrial Fibrillation Management and Outcomes
- Inhalation and Respiratory Drug Delivery
- Statistical Methods in Clinical Trials
- Tuberculosis Research and Epidemiology
- Antimicrobial Resistance in Staphylococcus
- Bacterial Identification and Susceptibility Testing
- Multiple Myeloma Research and Treatments
- Antibiotics Pharmacokinetics and Efficacy
- Monoclonal and Polyclonal Antibodies Research
- Chemical Reactions and Isotopes
- Pneumonia and Respiratory Infections
- CAR-T cell therapy research
- Cardiac Arrhythmias and Treatments
- Asthma and respiratory diseases
United States Food and Drug Administration
2024
University of North Carolina at Chapel Hill
2019-2023
Rivaroxaban is a direct-acting oral anticoagulant approved to prevent strokes in patients with atrial fibrillation. Dosage recommendations are for all adult receive either 15 mg or 20 once daily depending upon renal function. There number of reasons believe rivaroxaban dosing could be more effective and/or safer if increased precision available. Because real-world diverse than those studied phase III clinical trials, we evaluated the extremes creatinine clearance (CrCl) on using published...
Abstract On October 25, 2022, the FDA granted accelerated approval to teclistamab-cqyv (TECVAYLI; Janssen Biotech) for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines therapy, including a proteasome inhibitor, an immunomodulatory agent, and anti-CD38 mAb. Substantial evidence effectiveness was obtained from MajesTEC-1 trial, phase I/II, single-arm, open-label, multicenter study. Patients step-up doses teclistamab 0.06 0.3...
Tuberculosis (TB), caused by
Tuberculosis (TB), caused by Mycobacterium tuberculosis ( Mtb ), remains a leading cause of death with 1.6 million deaths worldwide reported in 2021. Oral pyrazinamide (PZA) is an integral part anti-TB regimens, but its prolonged use has the potential to drive development PZA resistant . converted active moiety pyrazinoic acid (POA) pyrazinamidase encoded pncA , and mutations are associated majority resistance. Conventional oral parenteral therapies may result subtherapeutic exposure lung,...
Population pharmacokinetic (PK)/pharmacodynamic models are commonly used to inform drug dosing; however, often real-world patients not well represented in the clinical trial population. We sought determine how dosing recommended rivaroxaban label results exposure for within a reference area under concentration-time curve (AUC) range. To accomplish this, we assessed utility of prior published population PK model predict patients. 230 using 3 methods: (1) patient phenotype information only,...