expanded access

Bosnian translation: proširen pristup

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:expanded access
Bosnian translation:proširen pristup
Entered by: V&E-Team

17:18 Jun 19, 2016
English to Bosnian translations [PRO]
Medical - Medical (general) / clinical trial
English term or phrase: expanded access
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.
V&E-Team
Croatia
Local time: 12:13
proširen pristup
Explanation:
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:
Selected response from:

LogosART
Croatia
Local time: 12:13
Grading comment
hvala
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1proširen pristup
LogosART


  

Answers


23 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
proširen pristup


Explanation:
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:

LogosART
Croatia
Local time: 12:13
Specializes in field
Native speaker of: Dutch
PRO pts in category: 32
Grading comment
hvala

Peer comments on this answer (and responses from the answerer)
agree  ipv
2 days 17 hrs
  -> Tnx a lot! Lijepi Vam pozdravi!
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