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A phase I, randomized, double‐blind, placebo‐controlled, single‐ and multiple dose escalation study evaluating the safety, pharmacokinetics and pharmacodynamics of VX‐128, a highly selective Nav1.8 inhibitor, in healthy adults
A phase I, randomized, double‐blind, placebo‐controlled, single‐ and multiple dose escalation study evaluating the safety, pharmacokinetics and pharmacodynamics of VX‐128, a highly selective Nav1.8 inhibitor, in healthy adults
Abstract Selective inhibition of certain voltage-gated sodium channels (Navs), such as Nav1.8, is of primary interest for ...
Imeglimin population pharmacokinetics and dose adjustment predictions for renal impairment in Japanese and Western patients with type 2 diabetes
Imeglimin population pharmacokinetics and dose adjustment predictions for renal impairment in Japanese and Western patients with type 2 diabetes
Abstract Imeglimin is an orally administered first-in-class drug to treat type 2 diabetes mellitus (T2DM) and is mainly ex...
Comparison of the influence of light between circularly polarized and linearly polarized smartphones on dry eye symptoms and asthenopia
Comparison of the influence of light between circularly polarized and linearly polarized smartphones on dry eye symptoms and asthenopia
Abstract This paper aims to investigate the efficacy of circularly polarized light smartphones in affecting dry eye sympto...
Chasing the storm: Recruiting non‐hospitalized patients for a multi‐site randomized controlled trial in the United States during the COVID‐19 pandemic
Chasing the storm: Recruiting non‐hospitalized patients for a multi‐site randomized controlled trial in the United States during the COVID‐19 pandemic
Abstract Randomized controlled trials (RCTs) remain the gold standard to evaluate clinical interventions, producing the hi...
Target to Treatment: a charge to develop biomarkers of response and tolerability in child and adolescent psychiatry
Target to Treatment: a charge to develop biomarkers of response and tolerability in child and adolescent psychiatry
Abstract The current pediatric mental health crisis is characterized by staggering rates of depression, anxiety, and suici...
A randomized crossover study comparing different tacrolimus formulations to reduce intrapatient variability in tacrolimus exposure in kidney transplant recipients
A randomized crossover study comparing different tacrolimus formulations to reduce intrapatient variability in tacrolimus exposure in kidney transplant recipients
Abstract A high intrapatient variability (IPV) in tacrolimus exposure is a risk factor for poor long-term outcomes after k...
Optimizing moxidectin dosing for Strongyloides stercoralis infections: Insights from pharmacometric modeling
Optimizing moxidectin dosing for Strongyloides stercoralis infections: Insights from pharmacometric modeling
Abstract Moxidectin is a frontrunner drug candidate in the treatment of strongyloidiasis. A dose of 8 mg is recommend...
Effect of cenobamate on the single‐dose pharmacokinetics of multiple cytochrome P450 probes using a cocktail approach in healthy subjects
Effect of cenobamate on the single‐dose pharmacokinetics of multiple cytochrome P450 probes using a cocktail approach in healthy subjects
ABSTRACT This study was designed to evaluate the effects of cenobamate, an antiseizure medication for focal seizures, on t...
A phase I, first‐in‐human, randomized dose‐escalation study of anti‐activated factor XII monoclonal antibody garadacimab
A phase I, first‐in‐human, randomized dose‐escalation study of anti‐activated factor XII monoclonal antibody garadacimab
Abstract Factor XII (FXII) is the principal initiator of the plasma contact system and has proinflammatory and prothrombot...
Endogenous metabolic markers for predicting the activity of dihydropyrimidine dehydrogenase
Endogenous metabolic markers for predicting the activity of dihydropyrimidine dehydrogenase
Abstract Five-fluorouracil (5-FU) is a chemotherapeutic agent that is mainly metabolized by the rate-limiting enzyme dihyd...
Natural Killer Cells in Liver Transplantation: Can We Harness the Power of the Immune Checkpoint to Promote Tolerance?
Natural Killer Cells in Liver Transplantation: Can We Harness the Power of the Immune Checkpoint to Promote Tolerance?
Abstract The roles that natural killer (NK) cells play in liver disease and transplantation remain ill-defined. Reports on...
Hydrogen sulfide donor protects against mechanical ventilation‐induced atrophy and contractile dysfunction in the rat diaphragm
Hydrogen sulfide donor protects against mechanical ventilation‐induced atrophy and contractile dysfunction in the rat diaphragm
Abstract Mechanical ventilation (MV) is a clinical tool providing adequate alveolar ventilation in patients that require r...
Population pharmacokinetics and exposure‐response modeling analyses of guselkumab in patients with psoriatic arthritis
Population pharmacokinetics and exposure‐response modeling analyses of guselkumab in patients with psoriatic arthritis
Abstract Guselkumab is an anti-interleukin-23 human monoclonal antibody effective in treating psoriatic arthritis (PsA). T...
Non‐synonymous alterations in AKR7A3 and ABCA6 correlate with bleeding in aged patients treated with rivaroxaban
Non‐synonymous alterations in AKR7A3 and ABCA6 correlate with bleeding in aged patients treated with rivaroxaban
Abstract Rivaroxaban is an oral anticoagulant that inhibits thrombin and blocks coagulation cascade through directly inact...
Pharmacokinetically guided dosing of oral sorafenib in pediatric hepatocellular carcinoma: A simulation study
Pharmacokinetically guided dosing of oral sorafenib in pediatric hepatocellular carcinoma: A simulation study
Abstract Sorafenib improves outcomes in adult hepatocellular carcinoma; however, hand foot skin reaction (HFSR) is a dose ...
Kinetics of myelin breakdown products: A labeling study in patients with progressive multiple sclerosis
Kinetics of myelin breakdown products: A labeling study in patients with progressive multiple sclerosis
Abstract The majority of disease modifying therapies for multiple sclerosis (MS) reduce inflammation, but do no’t t...
Pharmacokinetics of Bempedoic Acid in Patients With Renal Impairment
Pharmacokinetics of Bempedoic Acid in Patients With Renal Impairment
Abstract Bempedoic acid is an ATP citrate lyase inhibitor approved for the treatment of hypercholesterolemia. The objectiv...
Corrigendum to: Integrating real‐world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women
Corrigendum to: Integrating real‐world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women
Denise Beck, Insa Winzenborg, Wei Gao, Nael M. Mostafa, Peter Noertersheuser, Stephanie E. Chiuve, Charlotte Owens and Moh...
Pharmacokinetic/pharmacodynamic modeling for dose selection for the first‐in‐human trial of the activated Factor XII inhibitor garadacimab (CSL312)
Pharmacokinetic/pharmacodynamic modeling for dose selection for the first‐in‐human trial of the activated Factor XII inhibitor garadacimab (CSL312)
ABSTRACT Factor XII (FXII) is a serine protease involved in multiple cascades, including the kallikrein–kinin syste...
Physicochemical Properties Determining Drug Detection in Skin
Physicochemical Properties Determining Drug Detection in Skin
Abstract Chemicals, including some systemically administered xenobiotics and their biotransformations, can be detected non...
Wearable remote monitoring and COVID‐19
Wearable remote monitoring and COVID‐19
We would like to share ideas on the publication, “Closer to the Patient Means Better Decisions: Wearable Remote Monitoring...
Fear and food: Anxiety‐like behavior and the susceptibility to weight loss in an activity‐based anorexia rat model
Fear and food: Anxiety‐like behavior and the susceptibility to weight loss in an activity‐based anorexia rat model
Abstract Anorexia nervosa (AN) is a severe psychiatric disorder characterized by energy restriction, low body weight, a fe...
Efficacy of add‐on therapy with intravenous immunoglobulin in steroid hyporesponsive DRESS syndrome
Efficacy of add‐on therapy with intravenous immunoglobulin in steroid hyporesponsive DRESS syndrome
ABSTRACT Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a rare, potentially life-threatening, d...
Response to “Wearable Remote Monitoring and COVID‐19”
Response to “Wearable Remote Monitoring and COVID‐19”
Dear Editor, It is our pleasure to reply to the letter by Mungmumpuntipantip and Wiwanitkit. The author...
How can real‐world evidence aid decision making during the life cycle of nonprescription medicines?
How can real‐world evidence aid decision making during the life cycle of nonprescription medicines?
Abstract Real-world evidence (RWE) is an emerging scientific discipline which is being increasingly utilized for decision ...
To blind or not to blind first in human and exploratory clinical trials – acceleration of development vs. risk of bias
To blind or not to blind first in human and exploratory clinical trials – acceleration of development vs. risk of bias
ABSTRACT An IQ consortium (IQ) working group (WG) conducted a survey across multiple biopharmaceutical companies to gain i...
Effects of nurse‐led home‐based telephone support or home visits on cognitive function
Effects of nurse‐led home‐based telephone support or home visits on cognitive function
Abstract Patients undergone carotid revascularization surgery have a high risk of post-operative cognitive decline, and ho...
Increased serum amiodarone concentration in hypertriglyceridemic patients: effects of drug distribution to serum lipoproteins
Increased serum amiodarone concentration in hypertriglyceridemic patients: effects of drug distribution to serum lipoproteins
Abstract Amiodarone and its main metabolite, desethylamiodarone, are highly distributed to serum lipoproteins such as very...
Limited sampling strategies for estimation of tacrolimus exposure in kidney transplant recipients receiving extended‐release tacrolimus preparation
Limited sampling strategies for estimation of tacrolimus exposure in kidney transplant recipients receiving extended‐release tacrolimus preparation
Abstract Tacrolimus is the key component of most contemporary immunosuppressive drug regimens for the prevention of transp...
Prediction of human pharmacokinetics for low‐clearance compounds using pharmacokinetic data from chimeric mice with humanized livers
Prediction of human pharmacokinetics for low‐clearance compounds using pharmacokinetic data from chimeric mice with humanized livers
Abstract Development of low-clearance (CL) compounds that are slowly metabolized is a major goal in the pharmaceutical ind...
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