Примери за използване на Embryofoetal development на Английски и техните преводи на Български
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Embryofoetal development in rats and rabbits was not affected up to clinically relevant exposure(based on AUC).
In pregnant rats administered tasimelteon during the period of organogenesis,there were no effects on embryofoetal development.
An embryofoetal development study in rat confirmed the developmental toxicity and teratogenic potential of eribulin.
In the rabbit, sodium aminosalicylate had no effects on embryofoetal development; however, the doses evaluated were below those proposed clinically.
An embryofoetal development study has been conducted in monkeys administered lenalidomide at doses from 0.5 and up to 4 mg/kg/day.
Animal studies that have been conducted cannot rule out possible effects of anti-OP-1 antibodies on embryofoetal development(see section 5.3).
No effects on fertility or embryofoetal development were observed in rats and rabbits, except at doses related to maternal toxicity.
When gefitinib was administeredto rats during organogenesis, there were no effects on embryofoetal development at the highest dose(30 mg/kg/day).
No effects on fertility or embryofoetal development were observed in rats and rabbits, except at doses related to maternal toxicity.
Reproduction studies in the rat andthe rabbit showed no effect of agomelatine on fertility, embryofoetal development and pre- and post natal development. .
In embryofoetal development studies conducted in rats and rabbits, siponimod induced embryotoxic effects in the absence of maternal toxicity.
However, studies on the effect of HFA134a on the reproductive function and embryofoetal development in animals revealed no clinically relevant adverse effects.
Studies on embryofoetal development and pre-and postnatal development revealed eye malformations, skeletal anomalies, abortions, and an increased foetal death rate.
Animal studies are insufficient with respect to effects on pregnancy, embryofoetal development, parturition or postnatal development(see section 5.3).
Embryofoetal development studies were conducted in rats and rabbits at doses up to 39- and 34fold the estimated free clinical AUC for a 300 mg twice daily dose.
When gefitinib was administeredto rats during organogenesis, there were no effects on embryofoetal development at the highest dose(30 mg/kg/day).
The data available from a rat embryofoetal development study, where animals were given sodium aminosalicylate(3.85 to 385 mg/kg) were limited.
The MAH has provided data to demonstrate that doses of up to 700 mg/kg of ceftriaxone had no significant effect on fertility or embryofoetal development and the studies conducted are considered adequate.
Studies on embryofoetal development and pre-and postnatal development revealed eye malformations, skeletal anomalies, abortions, and an increased foetal death rate.
Non-clinical data reveal no special hazard for humans based on a series of studies investigating cardiovascular safety pharmacology, repeated dose toxicity,genotoxicity and toxicity to embryofoetal development.
In embryofoetal development studies, dasatinib likewise induced embryolethality with associated decreases in litter size in rats, as well as foetal skeletal alterations in both rats and rabbits.
Teratogenic effects on the aortic arches in combination with the heart andthe urogenital system were noted at an exposure 4 times higher than at the MRHD and on the embryofoetal development of the axial skeleton at an exposure 3 times higher than at the MRHD.
In the rabbit embryofoetal development study, following administration of Myozyme(10-40 mg/kg/day) with coadministration of diphenhydramine, a treatment-related increase in the incidence of abortions and early delivery was observed.
No significant placental transfer of methoxy polyethylene glycol-epetin beta was observed in the rat, andstudies in animals have not shown any harmful effect on pregnancy, embryofoetal development, parturition or postnatal development. .
No teratogenicity was observed in embryofoetal development studies in rats and rabbits at doses up to respectively 250 mg/kg/day and 450 mg/kg/day leading to exposures below the anticipated clinical exposure(based on AUC comparison).
In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs andother prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product should not be administered by pregnant women or women attempting to conceive.
Also there was no effect on embryofoetal development in rabbits at doses up to 150 mg/kg/day, the highest dose tested(0.3 to 0.5 times the human clinical exposure in ITP patients at 75 mg/day and HCV patients at 100 mg/day, based on AUC).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction and development, with the exception of a rat embryofoetal development study(subcutaneous administration).
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development but indicate a class-related reversible reduction in foetal weight(see section 5.3).
As the embryofoetal development investigations were performed in healthy pregnant animals and disease(such as diabetes) may modify the permeability of the placenta towards a Fab fragment, the study should be interpreted with caution.