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generini aplikacij atveju turi bti rodytas biologinis ekvivalentiskumas.
for generic applications bioequivalence must be demonstrated.
Last Update: 2008-03-04
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tyrim metu nustatyta stalevo ir atskir tableci biologinis ekvivalentiskumas.
the studies showed that stalevo is bioequivalent to the separate tablets.
Last Update: 2008-03-04
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referencinio ir bandomojo preparato biologinis ekvivalentiskumas buvo pakankamai rodytas, ir sios procedros metu nebuvo nagrinjamas.
the bioequivalence between the reference and test products was sufficiently proven and was not questioned in this referral.
Last Update: 2008-03-04
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taciau nustatytas eucreas ir kartu skiriam atskir vildagliptino bei metformino preparat biologinis ekvivalentiskumas (zr.
however, bioequivalence of eucreas with co-administered vildagliptin and metformin has been demonstrated (see section 5.2) .
Last Update: 2008-03-04
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2800 tv vitamino d3, esancio fosavance sudtyje, vien kart per savait vartojamos dozs ekvivalentiskumas 400 tv vitamino d vien kart per par dozei netirtas.
the equivalence of intake of 2800 iu of vitamin d3 weekly in fosavance to daily dosing of vitamin d 400 iu has not been studied.
Last Update: 2008-03-04
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komitetas, apsvarsts s klausim, nusprend, kad, remiantis turimais duomenimis, equimectin ir referencinio preparato biologinis ekvivalentiskumas nra rodytas.
the committee, having considered the matter, concluded that on the basis of the available data for equimectin bioequivalence with the reference product has not been shown.
Last Update: 2008-03-04
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aerius geriamojo tirpalo sudtyje esancio desloratadino koncentracija yra tokia pati, todl manoma, jog biologinis ekvivalentiskumas atitinka sirupo ir tableci ir tokio tyrimo atlikti nereikia.
as aerius oral solution contains the same concentration of desloratadine, no bioequivalence study was required and it is expected to be equivalent to the syrup and tablet.
Last Update: 2008-03-04
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pacientams po inkst transplantacijos, esant pastoviai koncentracijai, biologinis pasisavinimas skiriasi maziau, o terapinis ekvivalentiskumas patvirtintas randomizuotu tyrimu, kuriame dalyvavo 477 ligoniai.
the difference in bioavailability was less marked upon steady-state administration to renal transplant recipients, and therapeutic equivalence has been demonstrated in randomised study of 477 patients.
Last Update: 2008-03-04
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biologinis ekvivalentiskumas originaliam preparatui turi bti rodytas atitinkam biologinio prieinamumo tyrim bdu arba turi bti pateikti pakankamai issams duomenys apie likucius ir tokio vartojimo efektyvum.toki tyrim rezultatai arba minti duomenys turi bti pateikti atitinkamai nacionalinei organizacijai tolesniam vertinimui.
the bioequivalence with the originator product should be demonstrated by appropriate bioavailability study or adequate data should be provided with regard to residues and efficacy for this kind of application and the results of such study or such data should be submitted to the relevant national authority for further assessment.
Last Update: 2008-03-04
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veterinarini vaist komitetas (cvmp) nusprend, kad pagal europos sjungos reikalavimus meloxivet biologinis ekvivalentiskumas 1, 5 mg/ml geriamja suspensija tiekiamam preparatui metacam rodytas.
the committee for medicinal products for veterinary use (cvmp) considered that, in accordance with european union requirements, meloxivet has been shown to be bioequivalent to metacam 1.5 mg/ml oral suspension.
Last Update: 2008-03-04
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alendronato tyrimai per vieneri met daugiacentr tyrim, kuriame dalyvavo osteoporoze sergancios moterys po menopauzs, rodytas 70 mg alendronato (n=519) ir 10 mg kart per par vartojamo alendronato (n=370) terapinis ekvivalentiskumas.
alendronate studies the therapeutic equivalence of alendronate once weekly 70 mg (n=519) and alendronate 10 mg daily (n=370) was demonstrated in a one-year multicentre study of post-menopausal women with osteoporosis.
Last Update: 2008-03-04
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