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Once‐Daily Tacrolimus Extended‐Release Formulation: 1‐Year Post‐Conversion in Stable Pediatric Liver Transplant Recipients
The results support the safe and convenient conversion of pediatric liver transplant recipients from twice‐a‐day TAC to once‐daily XL. Expand
Prediction of the Plasma Concentration Profiles of Orally Administered Drugs in Rats on the Basis of Gastrointestinal Transit Kinetics and Absorbability
A new method based on gastrointestinal transit kinetics has been developed for estimation of the absorption profiles of drugs administered orally as aqueous solutions. The utility of the method wasExpand
A Phase 1, Randomized Ascending Single‐Dose Study of Antagonist Anti‐Human CD40 ASKP1240 in Healthy Subjects
In conclusion, antagonism of the CD40/CD154 interaction with ASKP1240 was safe and well tolerated at the doses tested. Expand
Effect of Renal or Hepatic Impairment on the Pharmacokinetics of Mirabegron
ResultsCompared with healthy subjects who were similar overall in terms of age, sex and body mass index (BMI), the geometric mean area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC∞) for mirabegron was 31, 66 and 118 % higher in subjects with mild, moderate and severe renal impairment, respectively. Expand
Single dose pharmacokinetics and absolute bioavailability of mirabegron, a β₃-adrenoceptor agonist for treatment of overactive bladder.
Mirabegron pharmacokinetics were linear after i.v. dosing, but exposure increased more than proportionally after oral dosing as a result of increased F, and the drug was in general well tolerated up to the highest doses studied. Expand
Role of Cytochrome P450 Isoenzymes 3A and 2D6 in the In Vivo Metabolism of Mirabegron, a β3-Adrenoceptor Agonist
To determine to what extent CYP3A and CYP2D6 isoenzymes are involved in mirabegron metabolism, two open-label, randomized, one-sequence crossover drug–drug interaction studies in healthy subjects were conducted to assess the effect of ketoconazole and rifampicin on the pharmacokinetics. Expand
Pharmacokinetics of an Elevated Dosage of Micafungin in Premature Neonates
The data suggest that 15 mg/kg dosing in premature neonates corresponds to an exposure of approximately 5mg/kg in adults, and no adverse events related to micafungin were observed. Expand
Safety and Pharmacokinetics of Repeat‐Dose Micafungin in Young Infants
The data suggest that micafungin dosages of 7 and 10 mg/kg/day are well tolerated and provide exposure levels that have been shown (in animal models) to be adequate for central nervous system coverage. Expand
Assessment of tacrolimus absorption from the human intestinal tract: open-label, randomized, 4-way crossover study.
Although this study was conducted in small group of healthy fasting men, the present results indicate that tacrolimus is suitable for MR formulation development due to a wide absorption window throughout the intestine in humans. Expand
Sex-dependent and independent renal excretion of nilvadipine metabolites in rat: evidence for a sex-dependent active secretion in kidney.
A clear presence of sex-dependent and independent active secretion mechanisms in the kidney has been demonstrated in rat and the female rat is able to eliminate 3 and 7 in urine by an active secretion mechanism that is inhibited by probenecid. Expand