Primjeri korištenja Exposure levels na Engleski i njihovi prijevodi na Hrvatskom
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primary foetotoxic effects were observed in animal studies in which the exposure levels of entacapone were markedly higher than the therapeutic exposure levels. .
Effects at exposure levels sufficiently in excess of clinical exposure levels indicate no special hazard for humans.
The potential for effects of aprepitant on fertility has not been fully characterised because exposure levels above the therapeutic exposure in humans could not be attained in animal studies.
there was an increased occurrence of renal tubular mineralization at exposure levels below clinical exposure levels. .
Effects on the development of the axial skeleton and on the development of the great arteries were also noted at subtherapeutic exposure levels.
In contrast, the 3-N-acetyl metabolite exposure levels were affected to a greater extent by renal impairment than those for amifampridine.
for these findings were below human clinical exposure levels at intended therapeutic dose.
Animal studies did not show any effects on fertility endpoints at area under the concentration time curve(AUC) exposure levels much higher than in patients receiving evolocumab at 420 mg once monthly see section 5.3.
seen in the dog at exposure levels similar to clinical use,
continuous exposure(1 day to 4 weeks at exposure levels of up to 10 times the clinical steady state plasma concentration)
daily doses giving exposure levels up to approximately 2-fold that achieved after a therapeutic dose in humans had no effect on the incidence
When canagliflozin/metformin was administered at 60/300 mg/kg/day(exposure levels 11 and 13 times the clinical exposure for canagliflozin and metformin,
They were reported at exposure levels(Cmax) approximately 7 to 13 fold(after 3
Lamivudine induces early embryolethality when administered to pregnant rabbits at exposure levels comparable to those achieved in man,
In rabbits doses of telbivudine providing exposure levels of 37 times those observed in humans at the therapeutic dose(600 mg)
independence is required concerning the activities of scientists belonging to the bodies responsible for setting maximum exposure levels in order to guarantee their objectivity.
In animal studies in mice, no adverse effects on fertility were observed in males at exposure levels 3-fold clinical exposure and in females at exposure levels 1-fold clinical exposure. .
In rats, decreased numbers of corpora lutea and implantation sites were observed at exposure levels equivalent to the maximum therapeutic dose in humans; irregular oestrus cycles and a decreased number of live foetuses were observed at exposure levels three times higher.
more transparency and independence is required concerning the activities of scientists belonging to the bodies responsible for setting maximum exposure levels in order to guarantee their objectivity.
severe hepatic impairment is recommended to achieve plasma exposure levels similar to patients with no hepatic impairment(see section 4.2).