Glossary entry (derived from question below)
English term or phrase:
OLE (open-label extension) study
Serbo-Croat translation:
otvorene metode ispitivanja
Added to glossary by
V&M Stanković
Feb 14, 2005 17:43
19 yrs ago
11 viewers *
English term
Bojana (X)
OLE (open-label extension) study
English to Serbo-Croat
Medical
Medical: Pharmaceuticals
clinical research study of a new treatment
Proposed translations
(Serbo-Croat)
| 4 | otvorene metode ispitivanja |
V&M Stanković
|
| 5 | otvorena produžna studija |
Sladjana Daniels
|
| 4 | otvorena proširena metoda studija |
Adnan Mustafa
|
Proposed translations
7 hrs
V&M Stanković
Serbia
Serbia
Native in Serbo-Croat
Works in field
Serbia
Sci/tech/leg. translators & Court transl
Native in: Serbian 
, Serbo-Croat
Works in: English to Serbian, Serbian to English, English to Serbo-Croat, and 5 more.
Related KudoZ points
:
7
Selected
otvorene metode ispitivanja
Otvorene metode (ispitivanja lekova), za razliku od “slepih” (placebo) metoda:
“ISPITNA PITANJA IZ FARMAKOLOGIJE I TOKSIKOLOGIJE
...
Otvorene i slepe metode ispitivanja lekova”
(www.medf.kg.ac.yu/katedre/k14/ispitna_ pitanja_iz_farmakologije_i_toksikologije.pdf )
“Department of Neurology, The University of Texas-Houston, Health Science Center
...
After the placebo-controlled extension of the pivotal US trial of glatiramer acetate for the treatment of relapsing multiple sclerosis ended, 208 participants entered an open-label, long-term treatment protocol...”
(http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d...
“Hrvatsko psihijatrijsko društvo
...
Obzirom na eticnost takve studije nisu provedene s placebo kontrolnom grupom, vec su one prospektivne, "open-label" dizajnirane.”
(http://www.hpd.htnet.hr/novosti/arhiv5.htm)
“ISPITNA PITANJA IZ FARMAKOLOGIJE I TOKSIKOLOGIJE
...
Otvorene i slepe metode ispitivanja lekova”
(www.medf.kg.ac.yu/katedre/k14/ispitna_ pitanja_iz_farmakologije_i_toksikologije.pdf )
“Department of Neurology, The University of Texas-Houston, Health Science Center
...
After the placebo-controlled extension of the pivotal US trial of glatiramer acetate for the treatment of relapsing multiple sclerosis ended, 208 participants entered an open-label, long-term treatment protocol...”
(http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d...
“Hrvatsko psihijatrijsko društvo
...
Obzirom na eticnost takve studije nisu provedene s placebo kontrolnom grupom, vec su one prospektivne, "open-label" dizajnirane.”
(http://www.hpd.htnet.hr/novosti/arhiv5.htm)
3 KudoZ points awarded for this answer.
Comment: "Nije bas najbolje resenje posto je rec o posebnom tipu klinicke studije, ali nemam ni sama bolju ideju. Svejedno hvala puno! Puno pozdrava"
2768 days
Adnan Mustafa
Albania
Albania
Specializes in field
Albania
Small Company-Smart Solutions
Native in: Albanian
Works in: English to Albanian, English to Serbo-Croat, Serbian to Albanian, and 4 more.
otvorena proširena metoda studija
open-label : otvorena metoda. extension:proširena. Radi se o otvorenoj proširenoj studiji. Tj. statistički uzorak je veći (proširen) u odnosu na standardni.
3598 days
Sladjana Daniels
Serbia
Serbia
Specializes in field
Serbia
Perfect blend of medicine and languages
Native in: Serbian
Works in: English to Serbian, Serbian to English
Related KudoZ points
:
4
otvorena produžna studija
Studija je "extension study" zato što se nadovezuje na prethodnu. U nju se pozivaju samo oni pacijenti koji su već učestvovali u prethodnoj (dakle, broj ispitanika u produžnoj studiji nikako nije povećan, može smo da bude isti ili smanjen). Ako se u prethodnoj nije znalo ko prima lek a ko placebo, u produžnoj se zna da svi primaju lek, zato je "open-label", tj. otvorena (doza može da bude maskirana).
Open label extension studies typically follow a double blind randomised placebo controlled trial of a new drug. At the end of the double blind phase, participants are invited to enrol in an extension study. The study will normally be longer than the randomised trial (two years is not uncommon but they often continue until the drug is licensed). All participants in the extension study are given the study drug, and both they and the investigators know this. The objective is primarily to gather information about safety and tolerability of the new drug in long term, day to day use.
http://www.bmj.com/content/331/7516/572
Open label extension studies typically follow a double blind randomised placebo controlled trial of a new drug. At the end of the double blind phase, participants are invited to enrol in an extension study. The study will normally be longer than the randomised trial (two years is not uncommon but they often continue until the drug is licensed). All participants in the extension study are given the study drug, and both they and the investigators know this. The objective is primarily to gather information about safety and tolerability of the new drug in long term, day to day use.
http://www.bmj.com/content/331/7516/572
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