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Population modelling of nilotinib exposure vs. longitudinal BCR::ABL1 response in patients with chronic phase chronic myeloid leukaemia using a semimechanistic disease model.
Br J Clin Pharmacol
December 2024
Novartis Pharma AG, Basel, Switzerland.
Aims: This study aims to evaluate the exposure-efficacy relationship of nilotinib and longitudinal BCR::ABL1 levels in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (CML-CP) and those who are imatinib-resistant or intolerant using a semimechanistic disease model.
Methods: The analysis included 489 CML-CP patients from 3 nilotinib trials (NCT00109707; NCT00471497; NCT01043874) with duration of follow-up ranging from 2 to 9 years. The semimechanistic disease model of CML-CP consisted of quiescent leukaemic stem cells, proliferating drug-susceptible and -resistant bone marrow cells.
Population pharmacokinetic modeling of zavegepant, a calcitonin gene-related peptide receptor antagonist, in healthy adults and patients with migraine.
CPT Pharmacometrics Syst Pharmacol
November 2024
Pfizer Inc., Groton, Connecticut, USA.
Article Synopsis
- Zavegepant (ZAVZPRET™) is a selective medication for treating acute migraines in adults, targeting specific receptors related to migraine pathways.
- A comprehensive analysis of its pharmacokinetics determined how zavegepant is absorbed, distributed, and eliminated from the body, utilizing data from multiple clinical trials.
- The findings revealed that zavegepant has low bioavailability rates when taken intranasally (5.1%) or orally (0.65%), with factors like age and sex not significantly affecting its pharmacokinetics, but certain conditions (like moderate liver impairment) could impact its clearance.
Population pharmacokinetics of long-term hydroxychloroquine therapy in patients with rheumatic diseases.
Br J Clin Pharmacol
September 2024
Department of Pharmacy, The First Affiliated Hospital of Anhui Medical University, Anhui Medical University, Hefei, Anhui, China.
Aims: Hydroxychloroquine (HCQ) is recommended for the long-term treatment of rheumatic diseases such as rheumatoid arthritis and systemic lupus erythematosus. Given the complex process of HCQ metabolism and individual physiological differences, the metabolic profile of HCQ after long-term administration is unknown. This study aimed to establish a population pharmacokinetic model for long-term HCQ treatment in patients with rheumatic diseases and to identify the factors influencing HCQ metabolism.
View Article and Find Full Text PDFImpact of the First Twenty-Four-Hour Area Under the Concentration-Time Curve/Minimum Inhibitory Concentration of Vancomycin on Treatment Outcomes in Patients With Methicillin-Resistant Bacteremia.
J Clin Med Res
August 2024
Department of Pharmacy, Fukuoka University Hospital, Jonan-ku, Fukuoka 814-0133, Japan.
Article Synopsis
- Vancomycin regimens aim for an AUC/MIC ratio of 400-600 µg·h/mL, but early treatment for severe infections may depend on the first 24-hour AUC/MIC measurements.
- This study analyzed MRSA bacteremia cases to see how the first 24-hour AUC/MIC impacted treatment outcomes, using a cutoff of 300 µg·h/mL to categorize patients.
- Results showed no significant difference in treatment efficacy or 30-day survival between groups, but those with an AUC/MIC < 300 had a longer time to clinical and bacteriological improvement, suggesting that while early AUC/MIC levels do not change success rates, they may influence recovery times.
Acute kidney injury is associated with abnormal cefepime exposure among critically ill children and young adults.
Pediatr Nephrol
February 2025
Division of Critical Care Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Background: Elevated cefepime blood concentrations can cause neurotoxicity in adults. The consequences of elevated cefepime concentrations among pediatric patients are unknown. Future exploration of such effects requires first identifying patients at risk for elevated cefepime exposure.
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