Iskalni niz je ali predolg ali pa vsebuje preveč besed.
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151–161/161
trial subject
151 Prevajalska redakcija
izobraževanje
CELEX: 32001L0020
The verification of compliance with the standards of good clinical practice and the need to subject data, information and documents to inspection in order to confirm that they have been properly generated, recorded and reported are essential in order to justify the involvement of human subjects in clinical trials.
Preverjanje skladnosti s standardi dobre klinične prakse in potreba, da se podatki, informacije in dokumenti pregledajo, da bi se potrdilo, da so bili pravilno pripravljeni, zapisani in da so o njih pravilno poročali, sta bistvena za to, da se upraviči vključevanje ljudi v klinično preskušanje.
152 Prevajalska redakcija
RS
EMEA
In a comparative trial in subjects aged 1-11 years, the incidences of local and general solicited symptoms in the Ambirix group were similar to those seen with the three-dose combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
V primerjalnem preskušanju pri osebah, starih od 1 do 11 let, je bila incidenca lokalnih in generaliziranih simptomov v skupini, ki je prejemala Ambirix, podobna tisti po prejemu treh odmerkov kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B.
153 Prevajalska redakcija
RS
EMEA
Reports of lack of effect, mainly in prophylaxis patients, have been received in the clinical trials and in the post-marketing setting for ReFacto. The reported lack of effect with ReFacto has been described as bleeding into target joints, bleeding into new joints or a subjective feeling by the patient of new onset 15 bleeding.
15 Poročila o neučinkovitosti, predvsem pri profilaktično zdravljenih bolnikih, prihajajo iz kliničnih preskušanj in iz postmarketinških opazovanj zdravila ReFacto.
154 Prevajalska redakcija
izobraževanje
CELEX: 31992L0086
Whereas, on the basis of the latest scientific and technical research, the use of strontium chloride, strontium acetate, fatty acid dialkanolamides, monoalkanolamines, trialkanolamines and hydrated magnesium silicate may be permitted subject to certain restrictions and conditions and the obligatory inclusion of health warnings on the label;
ker se lahko na podlagi najnovejših znanstvenih in tehničnih raziskav dovoli uporaba stroncijevega klorida, stroncijevega acetata, dialkanolamidov maščobnih kislin, monoalkanolaminov, trialkanolaminov in hidriranega magnezijevega silikata z nekaterimi omejitvami, pod določenimi pogoji in ob obveznem priloženem zdravstvenem opozorilu na etiketi;
155 Prevajalska redakcija
izobraževanje
CELEX: 32001L0020
Subject to any arrangements which may have been concluded between the Community and third countries, the Commission, upon receipt of a reasoned request from a Member State or on its own initiative, or a Member State may propose that the trial site and/or the sponsor's premises and/or the manufacturer established in a third country undergo an inspection.
Ob upoštevanju kakršnih koli dogovorov, ki jih je Skupnost morda sklenila s tretjimi državami, lahko Komisija po prejemu obrazložene zahteve države članice ali na svojo pobudo ali država članica predlagata, da se pregleda kraj preskušanja in/ali naročnikovi prostori in/ali proizvajalec, ki ima sedež v tretji državi.
156 Prevajalska redakcija
RS
EMEA
In clinical pharmacology trial WP18551, after a single dose intravenous administration of 6 mg (15 minutes infusion), mean AUC0-24 increased by 14 % and 86 %, respectively, in subjects with mild (mean estimated CLcr=68.1 mL/ min) and moderate (mean estimated CLcr=41.2 mL/ min) renal impairment compared to healthy volunteers (mean estimated CLcr=120 mL/ min).
V kliničnem farmakološkem preskušanju WP18551 se je po enkratnem 6- mg odmerku, danem intravensko (15 minutna infuzija), povprečna vrednost AUC0- 24 pri ljudeh z blago ledvično okvaro (ocenjeno povprečje CLcr = 68, 1 ml/ min) povečala za 14 %, pri ljudeh z zmerno ledvično okvaro (ocenjeno povprečje CLcr = 41, 2 ml/ min) pa za 86 % v primerjavi z zdravimi prostovoljci (ocenjeno povprečje CLcr = 120 ml/ min).
157 Prevajalska redakcija
RS
EMEA
In a pooled analysis of the POWER 1, 2 and 3 (see Clinical experience subsection) and DUET 1 and 2 (TMC125-C206 and TMC125-C216) trials the amino acid substitutions identified that developed on PREZISTA co-administered with ritonavir (600/100 mg b.i.d.) in ≥ 20% of the isolates from subjects who experienced virologic failure by rebound were V32I, I54L and L89V.
V analizi združenih podatkov preskušanj POWER 1, 2 in 3 (glejte podpoglavje Klinične izkušnje) ter preskušanj DUET 1 in 2 (TMC125- C206 in TMC125- C216) se je pri zdravilu PREZISTA z ritonavirjem (600/ 100 mg dvakrat na dan) pokazalo, da so se, pri ≥ 20 % izolatov, pri bolnikih, ki so že na predhodno zdravljenje razvili rezistenco, razvile zamenjave aminokislin V32I, I54L in L89V.
158 Prevajalska redakcija
izobraževanje
CELEX: 31997L0046
Whereas, however, Articles 3 (7) (e), 4 (5), 5 (5) and 12 (3c) of the said Directive provide for those rules not to apply to the introduction and movement of such harmful organisms, plants, plant products and other objects, for trial or scientific purposes and for work on varietal selections, subject to certain conditions which shall be determined at Community level;
ker členi 3(7)(e), 4(5), 5(5) in 12(3c) navedene direktive določajo, da se ta pravila ne uporabljajo za vnos in premeščanje škodljivih organizmov, rastlin, rastlinskih proizvodov in drugih predmetov v preskusne ali znanstvene namene in za delo pri žlahtnjenju pod pogoji, ki se določijo na ravni Skupnosti;
159 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
A clinical trial is any systematic study of medicinal products in human subjects whether in patients or non-patient volunteers in order to discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or study their absorption, distribution, metabolism and excretion in order to ascertain the efficacy and safety of the products.
Klinično preskušanje je vsaka sistematična študija zdravil na ljudeh, bolnikih ali zdravih prostovoljcih, ki ima namen odkriti ali potrditi učinke in/ali ugotoviti katere koli neželene učinke zdravil v preskušanju, in/ali raziskati absorpcijo, porazdelitev, presnovo in izločanje zdravila v preskušanju, da se preveri učinkovitost in varnost zdravil.
160 Prevajalska redakcija
RS
EMEA
In a pooled analysis of the POWER 1, 2 and 3 (see Clinical experience subsection ART-experienced patients) and DUET 1 and 2 (TMC125-C206 and TMC125-C216) trials the amino acid substitutions identified that developed on PREZISTA co-administered with ritonavir (600/100 mg b.i.d.) in ≥ 20% of the isolates from subjects who experienced virologic failure by rebound were V32I, I54L and L89V.
V analizi združenih podatkov preskušanj POWER 1, 2 in 3 (glejte podpoglavje Klinične izkušnje, Bolniki, ki imajo izkušenje z ART) ter preskušanj DUET 1 in 2 (TMC125- C206 in TMC125- C216) se je pri zdravilu PREZISTA z ritonavirjem (600/ 100 mg dvakrat na dan) pokazalo, da so se, pri ≥ 20 % izolatov, pri bolnikih, ki so že na predhodno zdravljenje razvili rezistenco, razvile zamenjave aminokislin V32I, I54L in L89V.
161 Prevod
promet
CELEX: 21990A1023(01)
This Agreement is concluded for an initial trial period of two years, after which the Agreement will either be subject to a joint review, or be renewed for a further period to be determined.
Ta sporazum se sklene za začetno poskusno obdobje dveh let. Po preteku tega dvoletnega obdobja se bo Sporazum skupaj pregledalo ali obnovilo za novo obdobje.
Prevodi: en > sl
151–161/161
trial subject