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(process b only) drug substance release testing: n.v.
(ainult protsess b) toimeaine kasutamiseks vabastamise testimine: n.v.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
the results indicate that the drug substance and drug product can be reproducibly manufactured.
tulemused näitavad, et toimeaine ja ravimpreparaadi tootmine on reprodutseeritav.
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
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(process a and b) drug substance release testing: pfizer ireland pharmaceuticals
(protsess a ja b) toimeaine kasutamiseks vabastamise testimine: pfizer ireland pharmaceuticals
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
the bulk drug substance manufacturing process also includes specific viral inactivation and removal steps.
toimeaine üldisesse tootmisprotsessi kuuluvad ka teatavad viiruste inaktiveerimise ja eemaldamise meetmed.
Last Update: 2017-04-26
Usage Frequency: 3
Quality:
therapeutic drug monitoring (tdm) or clinical monitoring of the affected substance is advised.
soovitatav on nende ravimite plasma kontsentratsiooni määramine (therapeutic drug monitoring, tdm) või kliiniline jälgimine.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
the drug substance and the drug product have been appropriately described and generally satisfactory documentation has been provided.
ravimi toimeainet ja ravimit on piisavalt kirjeldatud ja esitatud üldiselt rahuldav dokumentatsioon.
Last Update: 2012-04-11
Usage Frequency: 2
Quality:
this is justified, given the proteinous nature of the drug substance and the negative outcome of the genotoxicity testing.
see on põhjendatud sellega, et toimeaine on oma olemuselt looduslik proteiin ning genotoksilisusuuringute tulemused osutusid negatiivseteks.
Last Update: 2012-04-11
Usage Frequency: 2
Quality:
individuals who use drugs almost never restrict their consumption to a single substance.
uimastitarbijad ei piirdu peaaegu mitte kunagi ühe konkreetse ainega.
Last Update: 2014-02-06
Usage Frequency: 1
Quality:
the use of etoricoxib, as with any drug substance known to inhibit cox-2, is not recommended in women attempting to conceive.
etorikoksiibi, nagu ka teisi cox- 2 inhibeerivaid ravimeid, ei soovitata rasedust planeerivatel naistel kasutada.
Last Update: 2012-04-11
Usage Frequency: 4
Quality:
in animal studies with rats and dogs administered 59fe-velphoro drug substance orally, radiolabelled iron was recovered in the faeces but not the urine.
loomuuringutes, kus rottidele ja koertele manustati suu kaudu 59fe-velphoro ravimainet, leiti radiomärgistatud rauda väljaheites, aga mitte uriinis.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
as talimogene laherparepvec is injected and replicates intratumourally, bioavailability and systemic concentration of talimogene laherparepvec are not predictive of drug substance activity and therefore have not been evaluated.
talimogeenlaherparepvek’i süstitakse ja replitseerub tuumorisiseselt, mistõttu ei saa talimogeenlaherparepvek’i biosaadavuse ja süsteemse kontsentratsiooni alusel otsustada ravimi aktiivsuse üle ning seetõttu ei ole neid hinnatud.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
approximately 44% of an oral dose is recovered in the urine over 24 hours, with only 3.6% of the dose excreted as parent drug substance.
umbes 44% suukaudsest doosist eritus uriiniga 24 tunni jooksul, sellest ainult 3,6% eritus muutumatul lähteaine kujul.
Last Update: 2017-04-26
Usage Frequency: 3
Quality:
emedastine is absorbed systemically, as are other topically administered drug substances.
emedastiin, nagu teisedki paikselt manustatavad ravimid, imendub süsteemselt.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
a synthetic intermediate in manufacture of pazopanib, which is also present in the final drug substance in low amounts, was not mutagenic in the ames assay but genotoxic in the mouse lymphoma assay and in vivo mouse micronucleus assay.
pasopaniibi tootmise sünteetiline vaheprodukt, mida leidub väikestes kogustes ka ravimpreparaadis, ei olnud ames testis mutageenne, kuid oli genotoksiline hiire lümfoomitestis ja in vivo hiire mikronukleuste testis.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
other drug/substances should not be added or infused simultaneously through the same intravenous line.
teisi ravimeid/aineid ei tohi infusioonikotti lisada või manustada samaaegselt sama veenitee kaudu.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
from a quality point of view, xeomin is highly purified and differs from the drug substance in botox® and dysport® in that it is free of complexing proteins (haemagglutinins).
cmap- i vähenemine 4.
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
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one intermediate in the manufacturing process, which is also present in the final drug substance (< 0.15%), was positive for mutagenesis in an in vitro bacterial cell assay (ames test).
Üks vaheprodukt tootmisprotsessis, mis on ka lõplikus aines olemas (< 0, 15%), osutus mutageenseks in vitro bakteriraku testis (ames’ i test).
Last Update: 2012-04-11
Usage Frequency: 2
Quality:
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