A5083149023- Epilepsy research and treatment
- Pharmaceutical studies and practices
- Pharmacological Effects and Toxicity Studies
- Bipolar Disorder and Treatment
- Asthma and respiratory diseases
- Sleep and Work-Related Fatigue
- Transplantation: Methods and Outcomes
- Cholinesterase and Neurodegenerative Diseases
- HER2/EGFR in Cancer Research
- Pneumocystis jirovecii pneumonia detection and treatment
- Alzheimer's disease research and treatments
- Sleep and Wakefulness Research
- Antibiotics Pharmacokinetics and Efficacy
- Drug Transport and Resistance Mechanisms
- Drug-Induced Adverse Reactions
- Sleep and related disorders
- Advanced Multi-Objective Optimization Algorithms
- Cancer, Hypoxia, and Metabolism
- Advanced Breast Cancer Therapies
- Hemodynamic Monitoring and Therapy
- Statistical Methods in Clinical Trials
- Older Adults Driving Studies
- Biotin and Related Studies
- Thyroid Cancer Diagnosis and Treatment
- Chemotherapy-induced cardiotoxicity and mitigation
Eisai (United Kingdom)
2016-2025
Hudson Institute
2022
John Wiley & Sons (United States)
2022
University of Florida
2014
Eisai (Japan)
2012-2014
University of Hertfordshire
2013
University of Manchester
2003-2007
Papworth Hospital
2001-2004
To assess potential effects of lemborexant on next-morning driving performance in adult and elderly healthy volunteers.Randomized, double-blind, double-dummy, placebo active-controlled, four period incomplete crossover study 48 volunteers (22 females), 23-78 years old. Participants were treated at bedtime for eight consecutive nights with two three dose levels (2.5, 5, or 10 mg), zopiclone 7.5 mg (on the first last night intervening nights), placebo. Driving was assessed morning days 2 9...
Summary Purpose Although there is a general paucity of published pharmacokinetic ( PK ) data for new antiepileptic drugs AED s), analyses pooled from clinical studies perampanel have recently been presented. We present /pharmacodynamic PD phase III describing efficacy and safety as function exposure, in order to determine whether predictable concentration–effect relationship exists and/or adverse events AE s). The effects concomitant enzyme‐inducing s EIAED s) non–enzyme‐inducing on the...
Study 232, an open-label pilot study with extension phase, evaluated the pharmacokinetics and preliminary safety/tolerability efficacy of adjunctive perampanel oral suspension (≤0.18 mg/kg/d) in epilepsy patients aged ≥2 to <12 years. Patients were grouped into cohorts 1 (aged ≥7 years) 2 <7 years). The Core included pretreatment (≤2 weeks) treatment phases (7-week titration; 4-week maintenance; follow-up [for those not entering extension]). phase consisted 41-week maintenance periods....
Ketorolac was administered to 15 healthy volunteers in a phase 1, single‐dose, crossover, randomized study. Subjects received open‐label 15‐ and 30‐mg intramuscular (IM) ketorolac blinded intranasal (IN) ketorolac. The IN well tolerated; the only nasal symptoms were some instances of mild irritation. rapidly absorbed (median t max , 0.50–0.75 hours), half‐life approximately 5 6 hours, values that similar those following IM administration. Relative bioavailability compared administration at...
To evaluate the impact of perampanel and demographics on clearance concomitant antiepileptic drugs (AEDs), in patients with refractory partial-onset seizures.Pooled data from three Phase III clinical studies adjunctive were used. Blood samples for evaluation 11 AEDs taken during baseline (before initiation), at weeks 10, 14, 19 maintenance phase treatment (2-12 mg/day, once daily bedtime). Models estimating apparent each AED fitted to data, effects demographic variables determined. Final...
Aims To determine the population pharmacokinetics of artemether and dihydroartemisinin in African children with severe malaria acidosis associated respiratory distress following an intramuscular injection artemether. Methods Following a single (i.m.) 3.2 mg kg −1 artemether, blood samples were withdrawn at various times over 24 h after dose. Plasma was assayed for by gas chromatography‐mass spectrometry. The software program NONMEM used to fit concentration–time data investigate influence...
Abstract Lecanemab (Leqembi®) was recently approved by health authorities in the United States, Japan, and China to treat early Alzheimer's disease (AD), including patients with mild cognitive impairment (MCI) or dementia due upon confirmation of amyloid beta pathology. Extensively sparsely sampled PK profiles from 1619 AD subjects 21,929 serum lecanemab observations two phase I, one II, III studies were well characterized using a two‐compartment model first‐order elimination. The final...
Abstract Lemborexant is a novel orexin receptor antagonist approved in the United States and Japan for treatment of insomnia. This article describes population pharmacokinetics (PK) lemborexant relationship its daily steady‐state exposure (C av,ss ) to probability most frequent treatment‐emergent adverse events (TEAEs). The 12 230‐observation, 1892‐subject PK data set included from clinical studies with predominantly female subjects (66%) ranging age 18 88 years 37 168 kg body weight....
Recipients of organ transplants remain particularly dependent on prednisolone as part their maintenance immunosuppression. Despite this, the pharmacokinetics have never been fully characterized in these patients, and consequently dosing remains empirical. Accurate monitoring prednisolone, its primary metabolite prednisone, endogenous cortisol suppression such patients may provide a means improving clinical outcome by adjusting for variability pharmacodynamics. Measurement an independent...
Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor targeting vascular endothelial growth factor (VEGF) receptors 1-3, fibroblast (FGF) 1-4, platelet-derived receptor-α (PDGFRα), KIT, and RET that have been implicated in pathogenic angiogenesis, tumor growth, cancer. The primary objective of this work was to evaluate, by establishing quantitative relationships, whether lenvatinib exposure longitudinal serum biomarker data (VEGF, Ang-2, Tie-2, FGF-23) are predictors for change size which...
Aims To evaluate the population pharmacokinetics of levocetirizine in young children receiving long‐term treatment with cetirizine. Methods Data were available from a randomized, double‐blind, parallel group and placebo‐controlled study cetirizine 343 between 12 24 months age at entry, who high risk developing asthma, but not yet affected (ETAC ® study). Infants received oral drops 0.25 mg kg −1 twice daily for 18 months. Plasma concentration active enantiomer was determined blood samples...
Abstract Intravenous (IV) drug administration enables treatment of epilepsy when oral is temporarily not feasible. Perampanel a once‐daily antiseizure medication currently available as formulations. Study 050 (NCT03376997) was an open‐label, randomized, single‐dose, crossover study to evaluate the interchangeability and IV perampanel in healthy subjects (N = 48). Bioequivalence single 12‐mg doses (30‐, 60‐, or 90‐minute infusion) perampanel, ≥6 weeks apart, assessed. Analyses indicated...
Aims To evaluate retrospectively the population pharmacokinetics of cetirizine, a second‐generation antihistamine, in children. Methods Data were pooled from six clinical trials, which cetirizine was administered orally various formulations and single multiple dosage regimens. The consisted 112 children (33 female 79 male) aged 6 months to 12 years. A one‐compartment open model with first‐order absorption elimination fitted plasma concentration‐time profiles using nonlinear mixed effects...
To evaluate bioequivalence of perampanel oral suspension and tablet formulations under fasted fed conditions.
To explore perampanel exposure–response relationships for cognition and safety in pediatric patients (aged 4 to <12 years) with partial-onset seizures (POS) or primary generalized tonic-clonic (PGTCS) using pharmacokinetic/pharmacodynamic (PK/PD) analyses.
Abstract RATIONALE: Addition of CDK 4/6 inhibitors to endocrine therapy has become standard for patients (pts) with ER+ and HER2- BC improvements in overall survival. However, acquired resistance front-line is inevitable, response later-line poor. H3B-6545 a selective, orally available, small molecule covalent antagonist the estrogen receptor (ERα). binds covalently cysteine residue at position 530 both wild-type constitutively active mutant ERα proteins. demonstrated significant antitumor...