Glossary entry (derived from question below)
English term or phrase:
expanded access
Bosnian translation:
proširen pristup
Added to glossary by
V&E-Team
Jun 19, 2016 17:18
7 yrs ago
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English term
expanded access
English to Bosnian
Medical
Medical (general)
clinical trial
definicija: Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials.
primjer: In the case of XY however, subgroup analysis of the XY Phase 3 trial, as well as an expanded access program in a broader population of patients with metastatic RCC, demonstrated efficacy and feasibility in those with poor risk disease, suggesting that TKIs, notably XY, may be an alternative therapeutic option to mTOR inhibitors for this group of patients.
primjer: In the case of XY however, subgroup analysis of the XY Phase 3 trial, as well as an expanded access program in a broader population of patients with metastatic RCC, demonstrated efficacy and feasibility in those with poor risk disease, suggesting that TKIs, notably XY, may be an alternative therapeutic option to mTOR inhibitors for this group of patients.
Proposed translations
(Bosnian)
| 4 +1 | proširen pristup |
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Proposed translations
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proširen pristup
EXPANDED ACCESS: Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials.
PROŠIREN PRISTUP: Odnosi se na bilo koji postupak koji odobrava regulatorno tijelo,primjerice milosrdna uporaba, usporedno liječenje i liječenje pokusnim novim lijekom. U njima se pokusni lijek daje ispitanicima kod kojih ne djeluju trenutno dostupni lijekovi za njihovu bolest, a ne mogu sudjelovati u postojećim kliničkim
SOURCE:
Rječnik pojmova o kliničkim ispitivanjima
Ovaj je rječnik pomoć korisnicima u upoznavanju uobičajenih izraza koji se rabe u kliničkim ispitivanjima. Rječnik objavljujemo u dva prikaza:
PROŠIREN PRISTUP: Odnosi se na bilo koji postupak koji odobrava regulatorno tijelo,primjerice milosrdna uporaba, usporedno liječenje i liječenje pokusnim novim lijekom. U njima se pokusni lijek daje ispitanicima kod kojih ne djeluju trenutno dostupni lijekovi za njihovu bolest, a ne mogu sudjelovati u postojećim kliničkim
SOURCE:
Rječnik pojmova o kliničkim ispitivanjima
Ovaj je rječnik pomoć korisnicima u upoznavanju uobičajenih izraza koji se rabe u kliničkim ispitivanjima. Rječnik objavljujemo u dva prikaza:
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