Примери за използване на Exposures approximately на Английски и техните преводи на Български
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The NOAEL was associated with maternal plasma cannabidiol exposures approximately 9 times that in humans at 20 mg/kg/day.
In rats, at exposures approximately 3 times above clinical exposure, there was reduced fertility and an increased incidence of embryo-lethality, reductions in foetal weight and skeletal ossification and increased neonatal mortality.
Opportunistic infections related to demodicosis(mange)were observed in dogs at exposures approximately 7 times the human exposure. .
These effects occurred at exposures approximately 1.8 to 7 times human paediatric exposures at 10 mg(age 9 to 15 years), based on AUC.
Decreases in red blood cell parameterswere observed in mice, rats and dogs at exposures approximately 6 to 36 times the human exposure. .
No evidence of carcinogenicity was observed at exposures approximately 15, 13 and 39 times the estimated clinical AUC at the recommended starting dose in mice, male rats and female rats respectively.
Reversible ulcers anderosions in the gastro-intestinal tract occurred in dogs treated during 3 months at exposures approximately 7-fold the clinical AUC.
There were no effects on development in rats at exposures approximately 3-times greater than those at the maximum recommended human dose, based on AUC.
No adverse effects were seen in rats at exposures about 2-fold higher than humans,or in dogs at exposures approximately equal to humans.
In the dog, changes were observed in the liver andgall bladder at exposures approximately 8-fold higher than human exposure observed at the recommended dose(200 mg twice daily).
Non-clinical data revealed no special hazards for humans based on repeat-dose toxicity studies conducted in rats and cynomolgus monkeys andsafety pharmacology evaluations conducted in cynomolgus monkeys at exposures approximately 10 to 80 times higher than clinical exposures in patients receiving 240 mg.
A no observed effect level(NOEL) for pupil size was not established, butthe NOEL for impaired gait occurred at exposures approximately 11-times the human exposure resulting from the clinical dose of 400 mg and 8-times the human exposure resulting from the clinical dose of 500 mg(based on unbound Cmax in the respective species).
In a juvenile toxicology study in which rats were administered galcanezumab twice weekly from Postnatal Day 21 through 90, systemic effects were limited to reversible, minimal, nonadverse decreases in total bone mineral content andbone mineral density at exposures approximately 50 times the human exposure at 240 mg.
The major, inactive human metabolites of ombitasvir were not teratogenic in mice at exposures approximately 26 times higher than in humans at the recommended clinical dose.
No effects on male or female fertility and reproductive performance indices were observed at≤ 100 mg/kg/day(yielding exposures approximately 8 and 5 times, respectively, those obtained with the maximum recommended human dose of the ivacaftor component of Orkambi based on summed AUCs of ivacaftor and its metabolites extrapolated from Day 90 exposures at 100 mg/kg/day in the 6-month repeat-dose toxicity study and gestation Day 17 exposures in the embryofoetal development study in this species).
A study in Sprague-Dawley rats showed no adverse effects on embryo-fetal development at exposures approximately 135-fold the human exposure(based on Cmax).
Ivacaftor impaired fertility andreproductive performance indices in male and female rats at 200 mg/kg/day(yielding exposures approximately 11 and 7 times, respectively, those obtained with the maximum recommended human dose of the ivacaftor component of Orkambi based on summed AUCs of ivacaftor and its metabolites extrapolated from Day 90 exposures at 150 mg/kg/day in the 6-month repeat-dose toxicity study and gestation Day 17 exposures in the pilot embryofoetal development study in this species) when dams were dosed prior to and during early pregnancy.
Intravenous bolus dosing of ceftaroline fosamil to suckling rats from post-natal day 7 to 20 was well tolerated at plasma exposures approximately 2-fold higher than those for paediatric patients.
No target organs of toxicity were identified in rat anddog studies with ledipasvir at AUC exposures approximately 7 times the human exposure at the recommended clinical dose.
In reproductive toxicology studies, no evidence of impaired fertility was seen in male orfemale rats at systemic exposures approximately 14 times those observed in humans at the therapeutic dose.
In pre- and postnatal toxicity studies in rats,reduced weight gain of offspring was observed at maternal exposures approximately 4-times the maximal clinical exposure to empagliflozin.
The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats andmonkeys at doses that produce systemic exposures approximately 38 and 1.5 times the 50 mg human clinical exposure based on AUC, respectively.
In the pre- and postnatal toxicity study with linagliptin in rats, reduced weight gain in offspring was observed at maternal exposures approximately 1,500-times the maximal clinical exposure to linagliptin.
No teratogenic effects were observed in the rat andrabbit developmental toxicity studies with voxilaprevir at AUC exposures approximately 141- and 4-times higher, respectively, than the human exposure at the recommended clinical dose.
Voxilaprevir had no adverse effects on behavior, reproduction, or development of the offspring in the rat pre- andpost-natal development study at AUC exposures approximately 238-times higher than the human exposure at the recommended clinical dose.
The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats andmonkeys at doses that produce systemic exposures approximately 28.5 and 1.1 times the 50 mg human clinical exposure following single dose in the fasted state based on AUC, respectively.
In rabbits, embryofoetal lethality was observed at an exposure approximately 8 times higher than at the MRHD.
Population PK modeling indicates that exposure approximately doubles in patients with severe renal impairment(CrCL 15- 29 mL/min) relative to patients with normal renal function.
CYP3A4 inhibitors increase the exposure of lomitapide,with strong inhibitors increasing exposure approximately 27-fold.
The effect of selexipag on progression of PAH was demonstrated in a multi-centre,long-term(maximum duration of exposure approximately 4.2 years), double-blind, placebo-controlled, parallel-group, event-driven Phase 3 study in 1,156 patients with symptomatic(WHO FC I-IV) PAH.