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Model-Informed Development of a Cost-Saving Dosing Regimen for Sacituzumab Govitecan
BackgroundThe antibody–drug conjugate sacituzumab govitecan is approved for metastatic triple-negative breast cancer and has shown promising results...
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Supporting patients in the transition to the revised pexidartinib dosing regimen: perspectives from the multidisciplinary clinical and allied health professional team
Pexidartinib is a colony-stimulating factor-1 receptor inhibitor approved in the United States for treatment of adult patients with symptomatic...
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Implications of Oxybate Dosing Regimen for Sleep, Sleep Architecture, and Disrupted Nighttime Sleep in Patients with Narcolepsy: A Commentary
Narcolepsy is associated with disrupted nighttime sleep (DNS). Sodium oxybate (SXB; Xyrem ® ), administered twice nightly, is indicated for the...
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Population Pharmacokinetics of Digoxin in Nonagenarian Patients: Optimization of the Dosing Regimen
ObjectiveThe aim of this study was to develop a population pharmacokinetic model of digoxin in patients over 90 years old and to propose an equation...
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Anti-VEGF Drugs in Age-Related Macular Degeneration: A Focus on Dosing Regimen-Related Safety and Efficacy
Age-related macular degeneration (AMD) is one of the main causes of visual impairment and severe visual loss, and can progress to two advanced...
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A new dosing regimen of ropeginterferon alfa-2b is highly effective and tolerable: findings from a phase 2 study in Chinese patients with polycythemia vera
Ropeginterferon alfa-2b represents a new-generation pegylated interferon-based therapy and is administered every 2–4 weeks. It is approved for...
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Development of a Weight-Band Dosing Approach for Vosoritide in Children with Achondroplasia Using a Population Pharmacokinetic Model
Background and ObjectiveVosoritide is a recently approved therapy for achondroplasia, the most common form of disproportionate short stature, that...
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Meropenem Population Pharmacokinetics and Dosing Regimen Optimization in Critically Ill Children Receiving Continuous Renal Replacement Therapy
Background and ObjectiveWe aimed to develop a meropenem population pharmacokinetic model in critically ill children receiving continuous renal...
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Lacosamide dosing in patients receiving continuous renal replacement therapy
BackgroundLacosamide is one of the anticonvulsants used in critically ill patients. This study aimed to suggest appropriate lacosamide dosing...
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Impact of Key Components of Intensified Ceftaroline Dosing on Pharmacokinetic/Pharmacodynamic Target Attainment
Background and ObjectiveCeftaroline fosamil is a β-lactam antibiotic approved as a 600 mg twice daily dose (≤1 h infusion, ‘standard dosing’) or a...
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Exposure–Response Efficacy Modeling to Support Trofinetide Dosing in Individuals with Rett Syndrome
IntroductionTrofinetide was recently approved for the treatment of Rett syndrome (RTT) on the basis of the efficacy and safety findings of the...
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Cardiorespiratory consequences of attenuated fentanyl and augmented rocuronium dosing during protocolised prehospital emergency anaesthesia at a regional air ambulance service: a retrospective study
BackgroundPre-Hospital Emergency Anaesthesia (PHEA) has undergone significant developments since its inception. However, optimal drug dosing remains...
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Twice weekly dosing with Sebelipase alfa (Kanuma®) rescues severely ill infants with Wolman disease
BackgroundSebelipase alfa (Kanuma®) is approved for patients with Wolman disease (WD) at a dosage of 3–5 mg/kg once weekly. Survival rates in the...
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Comparison Pharmacokinetic Dosing Tools in Hemophilia A Children
Prophylaxis is the gold standard for the management of hemophilia A patients. It has been shown that prophylaxis regulated with pharmacokinetic (PK)...
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Dosing Optimization of Low-Sodium Oxybate in Narcolepsy and Idiopathic Hypersomnia in Adults: Consensus Recommendations
IntroductionLow-sodium oxybate (LXB) is approved for treatment of narcolepsy in patients aged 7 years and older and treatment of idiopathic...
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Optimization of levetiracetam dosing regimen in critically ill patients with augmented renal clearance: a Monte Carlo simulation study
BackgroundLevetiracetam pharmacokinetics is extensively altered in critically ill patients with augmented renal clearance (ARC). Consequently, the...
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Vancomycin and daptomycin dosing recommendations in patients receiving home hemodialysis using Monte Carlo simulation
BackgroundFew drug dosing recommendations for patients receiving home hemodialysis (HHD) have been published which has hindered the adoption of HHD....
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Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration Beyond One Year of Treatment: AZURE, a Randomized Trial of Treat-and-Extend vs. Fixed Dosing
IntroductionAZURE was a 76-week, randomized, open-label, parallel-group, phase IIIb noninferiority study comparing the efficacy and safety of...
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Busulfan target exposure attainment in children undergoing allogeneic hematopoietic cell transplantation: a single day versus a multiday therapeutic drug monitoring regimen
Busulfan exposure has previously been linked to clinical outcomes, hence the need for therapeutic drug monitoring (TDM). Study objective was to...