Examples of using Clinical development program in English and their translations into Slovenian
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Programming
Mitotane has not been studied in a comprehensive clinical development program.
Mitotana niso preučevali v obsežnem programu kliničnega razvoja.The clinical development program was composed by 5 studies provided in the following table:.
Klinični razvojni program je sestavljalo 5 študij, navedenih v naslednji tabeli:.During the clinical development program, 3,315 women(vaccine= 1,657 vs. placebo= 1,658) reported at least one pregnancy.
Med programom kliničnega razvoja so pri 3. 315 ženskah(cepivo= 1. 657, placebo= 1. 658) poročali o vsaj eni nosečnosti.Safety of ulipristal acetatehas been evaluated in 4,718 women during the clinical development program.
Varnost ulipristalacetata je bilaocenjena na vzorcu 4.718 žensk v času razvojnega kliničnega programa.In the asthma clinical development program a total of 7,034 patients were included in an integrated assessment of adverse reactions.
V programu kliničnega razvoja pri astmi je bilo v integrirano oceno neželenih učinkov vključenih skupno 7.034 bolnikov.The qHPV vaccine was used as an active control during the clinical development program for Gardasil 9.
V programu kliničnega razvoja cepiva Gardasil 9 so kot primerjalno učinkovino uporabljali qHPV cepivo.During the clinical development program, the occurrence of cases of melanoma prompted the consideration of a possible association with rasagiline.
V času programa kliničnega razvoja je pojavnost primerov melanoma nakazovala možnost povezave z razagilinom.No cases of overdose aftercutaneous use of Mirvaso were reported during the clinical development program.
O primerih prevelikegaodmerjanja po dermalni uporabi zdravila Mervaso med programom kliničnega razvoja niso poročali.The Phase III clinical development program for Kuvan included 2, randomised placebo-controlled studies in patients with PKU.
Faza III načrta kliničnega razvoja zdravila Kuvan je obsegala dve randomizirani, s placebom nadzorovani študiji pri bolnikih s PKU.The safety profile of Spedra isbased on 2436 subjects exposed to avanafil during the clinical development program.
Varnostni profil zdravila Spedra temelji napodatkih 2.436 posameznikov, ki so bili izpostavljeni avanafilu med programom kliničnega razvoja zdravila.The clinical development program has included over 1,900 patients, with different types of epilepsy, exposed to rufinamide.
V program kliničnega razvoja zdravila je bilo vključenih več kot 1. 900 bolnikov z različnimi vrstami epilepsije, ki so bili izpostavljeni rufinamidu.The safety profile of ANORO is based on safety experience with umeclidinium/vilanterol andthe individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Varnostne značilnosti zdravila ANORO temeljijo na izkušnjah z varnostjo kombinacije umeklidinij/vilanterol ins posameznima sestavinama iz programa kliničnega razvoja, ki je zajel 6.855 bolnikov s KOPB, in iz spontanega poročanja.However, during the clinical development program, a total of 10,476 pregnancies were reported including 5,387 in women who had received Cervarix.
Vendar so v času kliničnega razvojnega programa poročali o 10.476 primerih nosečnosti, vključno s 5.387 ženskami, ki so bile cepljene s cepivom Cervarix.The overall rate and pattern of adverse events, study drug discontinuation due to AEs, and the number of deaths reported in theseclinical studies were consistent with those observed during the clinical development programs for the lyophilised formulation.
Splošna stopnja in vzorec neželenih dogodkov, prekinitev študije zaradi neželenih dogodkov in število smrtnih primerov, o katerih so poročali v teh During the pre-licensure clinical development program, a total of 1,737 pregnancies were reported including 870 in women who had received Cervarix.
V času kliničnega razvojnega programa pred pridobitvijo dovoljenja za promet so poročali o 1. 737 primerih nosečnosti, vključno z 870 ženskami, ki so bile cepljene s cepivom Cervarix.The overall safety profile of Xadago is based on the clinical development program performed in over 3000 subjects, of whom over 500 were treated for more than 2 years.
Skupni varnostni profil zdravila Xadago temelji na programu kliničnega razvoja, ki so ga opravili z več kot 3000 preskušanci, od katerih je bilo prek 500 preskušancev zdravljenih več kot 2 leti.The clinical development program of fondaparinux in the treatment of venous thromboembolic events has been designed to demonstrate the efficacy of fondaparinux in the treatment of deep vein thrombosis(DVT) and pulmonary embolism(EP).
Klinični program za fondaparinuks pri zdravljenju venske trombembolije je bil oblikovan, da bi dokazal učinkovitost fondaparinuksa za zdravljenje globoke venske tromboze(DVT) in pljučne.The highest reported overdose in the clinical development program for lacosamide was 12 g taken in conjunction with toxic doses of multiple other antiepileptic drugs.
Največji odmerek, o katerem so poročali v programu kliničnega razvoja zdravila, je bil 12 g lakozamida, ki ga je bolnik vzel skupaj s toksičnimi odmerki več drugih antiepileptikov.The Keytruda clinical development program includes more than 30 tumor types in nearly 500 clinical trials, including more than 250 trials that combine pembrolizumab with other cancer treatments.
Program kliničnega razvoja zdravila pembrolizumab zajema več kot 30 vrst tumorjev v več kot 500 The KEYTRUDA clinical development program encompasses more than 30 tumor types in more than 500 clinical trials, including more than 300 trials that combine KEYTRUDA with other cancer treatments.
Program kliničnega razvoja zdravila pembrolizumab zajema več kot 30 vrst tumorjev v več kot 500 The KEYTRUDA clinical development program has rapidly expanded to encompass more than 30 tumor types in more than 130 clinical trials, of which more than 70 trials combine KEYTRUDA with other cancer treatments.
Program kliničnega razvoja zdravila pembrolizumaba se je hitro razširil, tako da je zajel več kot 30 vrst tumorjev v več kot 130 During the clinical development program of raltegravir in treatment-experienced patients, rash, irrespective of causality, was more commonly observed with regimens containing PREZISTA+ raltegravir compared to those containing PREZISTA without raltegravir or raltegravir without PREZISTA.
Med kliničnim razvojem raltegravirja pri bolnikih z izkušnjami s protiretrovirusnim zdravljenjem se je izpuščaj, ne glede na vzrok, pojavljal pogosteje pri shemi odmerjanja zdravila PREZISTA skupaj z raltegravirjem v primerjavi s shemo odmerjanja, ki je vsebovala samo zdravilo PREZISTA ali samo raltegravir.Taken altogether, the data from the non-clinical and clinical development program, which has been designed with support of Scientific Advice, provided sufficient evidence that a 1:1 dose ratio between Xeomin and Botox with respect to efficacy and safety can be concluded and the adoption of the dosage which has been established for Botox is adequately justified.
Kombinirani podatki iz nekliničnega in kliničnega razvojnega programa, ki je bil oblikovan ob podpori oddelka za znanstveno svetovanje, so prispevali zadosten dokaz, da je mogoče z ozirom na učinkovitost in varnost potrditi odmerjanje v razmerju 1: 1 med zdraviloma Xeomin in Botox ter da je uporaba odmerjanja, določenega za zdravilo Botox, zadostno utemeljena.The safety of Optaflu has been assessed in seven randomized,active controlled clinical trials performed as part of the development program.
Varnost cepiva Optaflu so ocenili v sedmih randomiziranih,aktivno nadzorovanih kliničnih preskušanjih, opravljenih kot del razvojnega programa.The commission already is funding researchaddressing Ebola under the E.U. 's Seventh Framework Program(FP7) for R&D: on the development of new antiviral drugs, on linking up high-security laboratories, on the clinical management of patients particularly in Europe and on solutions to ethical, administrative, regulatory and logistical bottlenecks that prevent a rapid research response.
Komisija že zagotavlja sredstva zaraziskave ebole v okviru sedmega okvirnega programa EU za raziskave in Actual developments or results could differ materially from those projected and depend on a number of factors including, but not limited to, the success of current research programs, results of pending or future clinical trials, ongoing commercialization of its products, regulatory approvals, validity and enforcement of its patents, the stability of its commercial relationships, and the general economic conditions.
Dejanski razvoj in rezultati bi se lahko bistveno razlikovali od načrtovanih in so odvisni od številnih dejavnikov, kar vključuje, vendar ni omejeno na uspeh tekočih raziskovalnih programov, rezultate kliničnih preskušanj v teku in prihodnje komercializacije izdelkov, registracije farmacevtskih izdelkov, veljavnost in uveljavljanje patentov, stabilnost komercialnih odnosov in splošne gospodarske pogoje.Actual developments or results could differ materially from those projected and depend on a number of factors including, but not limited to, the success of current research programs, results of pending or future clinical trials, ongoing commercialization of its products, regulatory approvals of GENERICSceuticals, validity and enforcement of its patents, the stability of its commercial relationships, and the general economic conditions.
Dejanski razvoj ali rezultati se lahko bistveno razlikujejo od predvidenih in so odvisni od številnih dejavnikov, kar med drugim vključuje tudi uspeh trenutnih raziskovalnih programov, rezultatov nerešenih ali prihodnjih kliničnih preskušanj, stalne komercializacije svojih izdelkov, regulativnih odobritev farmacevtskih izdelkov, veljavnost in uveljavljanje patentov podjetja, stabilnost trgovinskih odnosov podjetja in splošne gospodarske razmere.Actual developments or results could differ materially from those projected and depend on a number of factors including, but not limited to, the success of current research programs, results of pending or future clinical trials, ongoing commercialization of its products, regulatory approvals of pharmaceuticals, validity and enforcement of its patents, the stability of its commercial relationships, and the general economic conditions.
Dejanski razvoj in rezultati bi se lahko bistveno razlikovali od načrtovanih in so odvisni od številnih dejavnikov, kar vključuje, vendar ni omejeno na uspeh tekočih raziskovalnih programov, rezultate kliničnih preskušanj v teku in prihodnje komercializacije izdelkov, registracije farmacevtskih izdelkov, veljavnost in uveljavljanje patentov, stabilnost komercialnih odnosov in splošne gospodarske pogoje.
