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genotoksiskuma pārbaude
genotoxicity testing
Ultimo aggiornamento 2014-11-21
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genotoksiskuma testi:
genotoxicity tests:
Ultimo aggiornamento 2014-11-21
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veic genotoksiskuma pētījumus.
genotoxicity shall be studied.
Ultimo aggiornamento 2014-11-21
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prognozēt genotoksiskuma iespējamību,
predict genotoxic potential,
Ultimo aggiornamento 2014-11-21
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genotoksiskuma testēšanas mērķis ir:
the aim of genotoxicity testing shall be to:
Ultimo aggiornamento 2014-11-21
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somatisko šūnu genotoksiskuma pārbaudes, piemēram,
genotoxicity tests in somatic cells such as:
Ultimo aggiornamento 2014-11-21
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izavukonazolam nav nosakāms mutagenitātes vai genotoksiskuma potenciāls.
isavuconazole has no discernible mutagenic or genotoxic potential.
Ultimo aggiornamento 2017-04-26
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cilmes šūnu mutagenitātes/genotoksiskuma pārbaudes, piemēram,
mutagenicity/genotoxicity tests in germ cells, such as:
Ultimo aggiornamento 2014-11-21
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standarta genotoksiskuma pārbaudes neuzrāda specifisku risku cilvēkiem.
a standard battery of genotoxicity test reveals no specific hazard for humans.
Ultimo aggiornamento 2012-04-10
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genotoksiskuma pārbaudes rezultātus parasti uzskata par mutagēnās ietekmes rādītājiem.
genotoxicity test results are usually taken as indicators for mutagenic effects.
Ultimo aggiornamento 2014-11-21
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genotoksiskuma un reprodukcijas standartpētījumos ar šķīdinātāju sbecd īpašs risks cilvēkam netika atklāts.
standard genotoxicity and reproduction studies with the excipient sbecd reveal no special hazard for humans.
Ultimo aggiornamento 2017-04-26
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tradicionālie kancerogēniskuma un genotoksiskuma pētījumi nav vajadzīgi, veic tikai zāļu tumoroģenētiskā potenciāla pētījumu.
conventional carcinogenicity and genotoxicity studies shall not be required, except with regard to the tumourigenic potential of the product.
Ultimo aggiornamento 2014-11-21
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citām in vivo somatisko šūnu genotoksiskuma pārbaudēm, kuras apstiprina in vitro mutagenitātes vērtējumos gūti pozitīvi rezultāti.
other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
Ultimo aggiornamento 2014-11-21
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apsver attiecīgu in vivo mutagēnuma izpēti, ja kādai no vii vai viii pielikumā minētajām genotoksiskuma izpētēm ir pozitīvs rezultāts.
appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in annex vii or viii.
Ultimo aggiornamento 2014-02-06
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attiecībā uz 25. metabolītu zinātnes ekspertu grupa nevarēja pieņemt secinājumu, ka šis metabolīts genotoksiskuma sakarā ir nekaitīgs.
for metabolite 25 the scientific panel was unable to conclude that this metabolite was safe from the point of view of genotoxicity.
Ultimo aggiornamento 2014-11-21
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apsver attiecīgu in vivo mutagēnuma izpēti, ja kādai no vii vai viii pielikumā minētajām genotoksiskuma izpētēm ir pozitīvs rezultāts.
appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in annex vii or viii.
Ultimo aggiornamento 2014-11-21
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ja viela ir klasificēta kā 1. vai 2. kategorijas mutagēna, var pieņemt kā ticamu, ka attiecībā uz kanceroģenēzi darbojas genotoksiskuma mehānisms.
if the substances is classified as mutagen category 1 or 2, the default presumption would be that a genotoxic mechanism for carcinogenicity is likely.
Ultimo aggiornamento 2014-11-21
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viela ir klasificēta kā 1.a vai 1.b kat. mutagēns – tad var pieņemt, ka kancerogenitātei ir iespējams genotoksiskuma mehānisms.
the substance is classified as mutagen category 1a or 1b. the default presumption would be that a genotoxic mechanism for carcinogenicity is likely.
Ultimo aggiornamento 2014-11-21
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nav veikti myocet genotoksiskuma, kancerogenitātes un reproduktīvā toksiskuma pētījumi, taču ir zināms, ka doksorubicīns ir gan mutagēns, gan kancerogēns un var izraisīt reproduktīvo toksiskumu.
studies of genotoxicity, carcinogenicity and reproductive toxicity of myocet have not been performed but doxorubicin is known to be both mutagenic and carcinogenic and may cause toxicity to reproduction.
Ultimo aggiornamento 2017-04-26
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reģistrētājs ierosina attiecīgu in vivo somatisko šūnu genotoksiskuma izpēti, ja kādā no vii vai viii pielikumā minētajiem in vitro genotoksiskuma izpētei ir pozitīvs rezultāts un nav pieejamu rezultātu in vivo izpētē.
if there is a positive result in any of the in vitro genotoxicity studies in annex vii or viii and there are no results available from an in vivo study already, an appropriate in vivo somatic cell genotoxicity study shall be proposed by the registrant.
Ultimo aggiornamento 2014-11-21
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