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Randomized, Open-Label Study of the Pharmacokinetics and Safety of Oral and Intravenous Administration of Omadacycline to Healthy Subjects
ABSTRACT Omadacycline is a first-in-class aminomethylcycline antibiotic with microbiological activity against Gram-positive and Gram-negative aerobes and anaerobes and atypical bacteria that is beingExpand
Expression of Multidrug Resistance-Associated Protein (MRP) in Human Retinal Pigment Epithelial Cells and Its Interaction with BAPSG, a Novel Aldose Reductase Inhibitor
TLDR
MRP is functionally and biochemically active in human RPE cells and anionic BAPSG, a novel anionic aldose reductase inhibitor, is a likely substrate for MRP. Expand
Influence of pH and Temperature on Kinetics of Ceftiofur Degradation in Aqueous Solutions
TLDR
The stability of ceftiofur in aqueous solutions at various pH and temperature conditions was evaluated and its degradation product, desfuroylceftio Fur, in the incubation solutions was quantified. Expand
In vitro and clinical evaluation of OATP‐mediated drug interaction potential of sacubitril/valsartan (LCZ696)
Sacubitril/valsartan (LCZ696) has been recently approved for the treatment of heart failure (HF) patients with reduced ejection fraction. Several HF patients receive statins as co‐medication.
Pharmacokinetics of Valsartan in Pediatric and Adolescent Subjects With Hypertension
TLDR
Dose‐normalized maximum plasma concentration and area under the plasma‐concentration curve and body weight—normalized apparent oral clearance are comparable for the 4 groups, and major pharmacokinetic parameters are dose normalized for comparison across the age groups. Expand
Dose Proportionality and the Effect of Food on Vildagliptin, a Novel Dipeptidyl Peptidase IV Inhibitor, in Healthy Volunteers
TLDR
Vildagliptin displays approximately dose‐proportional pharmacokinetics over the 25‐ to 200‐mg dose range, and administration with food has no clinically relevant effect on vildag Liptin pharmacokinetic. Expand
Vildagliptin, a Novel Dipeptidyl Peptidase IV Inhibitor, Has No Pharmacokinetic Interactions With the Antihypertensive Agents Amlodipine, Valsartan, and Ramipril in Healthy Subjects
TLDR
Vildagliptin was generally well tolerated when given alone or in combination with amlodipine, valsartan, or ramipril in healthy subjects at steady state and no adjustment in dosage based on pharmacokinetic considerations is required. Expand
Evaluation of the potential for steady-state pharmacokinetic interaction between vildagliptin and simvastatin in healthy subjects*
TLDR
The data indicate that the rate and extent of absorption of vildagliptin and simvastatin were not affected when co-administered, nor was the metabolic conversion of simVastatin to its active metabolite altered. Expand
Pharmacokinetics and Pharmacodynamics of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis
TLDR
Body‐weight–based dosing provided comparable canakinumab exposure across the age groups in patients 2 to <20 years with SJIA, and a modest increase in the turnover rate of IL‐1β was observed, in younger children. Expand
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