Примери за използване на Clinically relevant exposures на Английски и техните преводи на Български
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These findings were observed at clinically relevant exposures.
Phospholipidosis was observed in the lungs of rats, dogs, and mice(with or without inflammation) andin the adrenal gland cortex of dogs at clinically relevant exposures.
Based on testicular toxicity in dogs at clinically relevant exposures, male fertility may be compromised by treatment with venetoclax(see section 5.3).
Rucaparib down regulated CYP2B6 in human hepatocytes at clinically relevant exposures.
Additional findings at clinically relevant exposures included faecal changes; skeletal muscle twitching or tremors; alopecia; swelling, follicular hyperkeratosis, and inflammation in paw pads; and increased LDL and HDL cholesterol.
A mild hypotensive effect has been observed in monkeys at around clinically relevant exposures.
These effects observed at clinically relevant exposures include closure of bone growth plates, effects on growing teeth, effects on the male and female reproductive tract, atrophy of the hair follicles with alopecia, gastrointestinal toxicity with body weight loss and effects on lymph nodes.
The infertility associated with migalastat treatment was reported at clinically relevant exposures.
Administration of cariprazine to pregnant rats duringthe period of organogenesis, throughout pregnancy and lactation at clinically relevant exposures decreased postnatal survival, birth weight, and post-weaning body weight of first generation pups.
There are no data from the use of indacaterol in pregnant women available. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures(see section 5.3).
These systemic toxicities were generally observed at clinically relevant exposures based on AUC.
Reproductive toxicity studies conducted in rats and rabbits showed an increased incidence in skeletal variations(changes in the numbers of ribs and delayed ossification), embryo-fetal lethality(periimplantation loss and resorptions) and some evidence of an increase in stillbirths(rats only),in the absence of maternal toxicity, at clinically relevant exposures.
In female rats, lower fertility andconception indices were observed at clinically relevant exposures based on mg/m2 body surface area.
In developmental toxicity studies in rabbits and cynomolgus monkeys, increased pregnancy loss andslightly increased incidence of foetal abnormalities were observed at clinically relevant exposures.
In female mice, an increased incidence of mammary gland adenocarcinoma and adeno-squamous carcinoma, andpars distalis adenoma of the pituitary gland, was observed at similar or even lower clinically relevant exposures: these prolactin-mediated endocrine tumours were also observed in rodents with other antipsychotics and their clinical relevance is unknown.
Rucaparib induced CYP1A2, and down regulated CYP2B6 andCYP3A4 in human hepatocytes at clinically relevant exposures.
In individual monkeys, severe thrombocytopenia was noted in the 9 month study of drug treated groups at clinically relevant exposures and has also been observed in clinical studies.
Increased incidence of retinal degeneration/atrophy was observed in albino rats in the 2-year study at clinically relevant exposures.
However, irreversible defects in growing teeth and premature closure of the femoral epiphyseal plate,observed in rat toxicity studies at clinically relevant exposures, represent risks to post-natal development.
Brexpiprazole did not show any genotoxic potential in both in vitro andin vivo studies using clinically relevant exposures.
In cynomolgus monkeys, the incidence and severity of arterial inflammationwas dose dependent and observed in a wide range of organs and tissues at clinically relevant exposures in the 4- and 39-week repeat-dose toxicology studies.
In embryo-foetal development studies in rats, semaglutide caused embryotoxicity below clinically relevant exposures.
In 2-year carcinogenicity studies in rats and mice,semaglutide caused thyroid C-cell tumours at clinically relevant exposures.
Animal studies donot indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures(see section 5.3).
There were no margins to clinically relevant exposure of aprepitant.
There were no margins to clinically relevant exposure.
Thus, dacomitinib is not expected to be genotoxic at clinically relevant exposure concentrations.
Like a number of other quinolones,ciprofloxacin is phototoxic in animals at clinically relevant exposure levels.
In rats, increased IgG andIgA plasma levels were seen at clinically relevant exposure levels.
Animal studies showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.