Примери за използване на Anticipated clinical на Английски и техните преводи на Български
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In animal studies EVARREST was absorbed by 56 days when used at the anticipated clinical dose.
The anticipated clinical exposure to hydroxypropylbetadex with intravenously administered letermovir is expected to be approximately 3600 mg/day for a letermovir dose of 480 mg.
These NOAEL doses were associated with systemic exposures(based on AUC) up to 9.7 and 2.1 times,respectively, anticipated clinical exposure.
The anticipated clinical benefit resulting from a combination of dinotefuran with permethrin was demonstrated in one laboratory study on dogs which showed a prolongation of the duration of efficacy against C. canis fleas to 4 weeks.
Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical plasma levels.
The anticipated clinical benefit resulting from a combination of dinotefuran with permethrin was demonstrated in one laboratory study on dogs which showed a prolongation of the duration of efficacy against C. canis fleas to 4 weeks.
These no observed adverse effect level(NOAEL) doses were associated with systemic exposures up to 2.5 times greater than anticipated clinical exposure.
Therefore, patients with severe renal impairment orend-stage renal disease should be treated with ataluren only if the anticipated clinical benefit outweighs the potential risk, and should be closely monitored for possible metabolite toxicity and decrease in efficacy.
There is also potential to induce incidences of premature ventricular contractions(PVCs) at elevated exposures(approximately 5-fold the anticipated clinical Cmax).
Reversible toxic effects(hepatocellular necrosis and degeneration)in the liver at exposures below the anticipated clinical exposure(based on AUC comparisons) were noted in the 13-week dog study.
In a pre- and postnatal developmental rat study, pup mortality, absence of milk in the stomach andneonatal hepatotoxicity were observed at dose levels similar to the anticipated clinical exposure.
Patients with severe renal impairment(eGFR< 30 ml/min) orend-stage renal disease should be treated with ataluren only if the anticipated clinical benefit outweighs the potential risk(see sections 4.2 and 4.4).
Shortening of the gestation period andassociated increased incidence of premature births were observed in pregnant monkeys at doses of≥ 0.3 mg/kg which corresponded to burosumab exposures that are≥0.875- to 1.39-fold anticipated clinical levels.
Repeat-dose toxicity studies revealed changes(degenerations and regenerations)in various organs at exposures below the anticipated clinical exposure(based on AUC comparisons).
Onpattro has not been studied in patients with moderate or severe hepatic impairment andshould not be used in these patients unless the anticipated clinical benefit outweighs the potential risk(see section 5.2).
Focal bone marrow necrosis was noted in one dog in a prematurely terminated 39-week BID dog study at exposures similar to the anticipated clinical exposure(based on AUC comparisons).
Onpattro has not been studied in patients with severe renal impairment or end-stage renal disease andshould not be used in these patients unless the anticipated clinical benefit outweighs the potential risk(see section 5.2).
No teratogenicity was observed in embryofoetal development studies in rats and rabbits at doses up to respectively 250 mg/kg/day and450 mg/kg/day leading to exposures below the anticipated clinical exposure(based on AUC comparison).
Vemurafenib was shown to be phototoxic, in vitro, on cultured murine fibroblasts after UVA irradiation, butnot in vivo in a rat study at doses up to 450 mg/kg/day at exposures below the anticipated clinical exposure(based on AUC comparison).
However, in repeat-dose toxicity studies, no histopathological findings were noted on reproductive organs in males and females in rats anddogs at doses up to 450 mg/kg/day(at exposures below the anticipated clinical exposure based on AUC comparison).
However, testicular(hypocellularity of the seminiferous epithelium) and ovarian changes(follicular atresia) were observed in repeated-dose toxicity studies in animals at exposures 11 to 15 times(rat) or0.6 to 7 times(monkey) the anticipated clinical exposure(based on AUC) at the maximum tolerated human dose.
No environmental impact is anticipated from the clinical use of pioglitazone.
This survival was greater than the six-to-nine month median survival anticipated by consultant clinical investigators for a similar patient population.
Only in exceptional circumstances, when the anticipated incremental clinical benefit justifies the increased risk of hepatic reactions, should the dose be increased to 200 mg three times daily.
Environmental Risk Assessment: no environmental impact is anticipated from the clinical use of either of the active substances canagliflozin or metformin in Vokanamet.
Some of the clinical ECTS are anticipated to the first years, while some of the pre-clinical ECTS are postponed to the III-IV-V years.
The maternal doses administered in this study resulted in maximum mean serum concentrations(Cmax)that were 4.5- and 21-fold above those anticipated in the clinical setting.
Only in exceptional circumstances, when the anticipated incremental clinical benefit justifies the increased risk of hepatic reactions, should the dose be increased to 200 mg three times daily(see sections 4.4 and 4.8).
Reproductive studies have been performed in pregnant cynomolgus monkeys receiving belimumab 150 mg/kg by intravenous infusion(approximately 9 times the anticipated maximum human clinical exposure) every 2 weeks for up to 21 weeks, and belimumab treatment was not associated with direct or indirect harmful effects with respect to maternal toxicity, developmental toxicity.
Before a clinical trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial patient and society.