Examples of using Toxicity study in English and their translations into Romanian
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Effects on endocrine active and reproductive system organs were not observed in a chronic cynomolgus monkey toxicity study and reproductive performance was not affected in IL-6 deficient mice.
Such effects were not seen in the male animals of that study or in the 13 weeks repeated dose toxicity study in rats(without recovery).
The sub-chronic toxicity study(90 days)(Tier II,
The sub-chronic toxicity study(90 days)(Annex IX, Section 8.6.2)
In a repeat dose toxicity study in juvenile rats,
In addition, in the vismodegib general 26-week toxicity study, decreased number of corpora lutea was observed at 100 mg/kg/day;
In another juvenile toxicity study in 14-day old rats,
seen at clinically relevant doses in the repeated dose monkey toxicity study is not known.
A long-term repeated toxicity study(≥ 12 months) may be proposed by the registrant or required by the Agency in accordance with Articles 40 or 41 if the frequency
No definitive conclusion can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study, but given the lack of binding of vedolizumab to male reproductive tissue in monkey
In a juvenile rat toxicity study, pups dosed from postnatal day 7 to 63 with 10,
either a pre-natal developmental toxicity study(Tier II, section 6.7.2) or a two generation reproductive toxicity study(Tier II, section 6.7.3) may be proposed by the applicant instead of the screening study. .
45 mg/kg in the single dose toxicity study and at 1, 2.5 and 5 mg/kg in the 4-week repeat-dose toxicity study.
as a consequence, that no further animal safety studies with the whole food/feed(e.g. a 90-day toxicity study in rats) are needed.
Subacute toxicity studies did not reveal any unexpected adverse events.
Acute toxicity studies shall be carried out in at least two mammalian species.
Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.
Aripiprazole did not impair fertility in reproductive toxicity studies.
The finding did not occur in mouse or rat toxicity studies.
Juvenile animal toxicity studies.