Glossary entry (derived from question below)
русский term or phrase:
регистрационное клиническое исследование
английский translation:
Registration Study
Added to glossary by
Judith Hehir
Jul 24, 2013 16:57
11 yrs ago
6 viewers *
русский term
регистрационное клиническое исследование
русский => английский
Медицина
Медицина: Фармацевтика
type of study
Регистрационное клиническое исследование III фазы
This appears under Вид исследования.
Thank you.
This appears under Вид исследования.
Thank you.
Proposed translations
(английский)
| 4 +2 | Registration Study |
Natalie
|
| 3 +2 | registered clinical trial |
Allison Keating
|
| 3 | clinical trial for the purpose of a marketing authorization |
Olga Avdeeva
|
Proposed translations
+2
2 час
Selected
Registration Study
Sometimes also "Core Registration Study". Olga is right about the meaning, but this is how it is called in English (I have just finished translating a protocol for a registration study).
Definition from Lilly's glossary:
Core Registration Studies: Those primary safety and efficacy studies that the relevant government health agency uses to decide whether or not to approve the investigational drug or new use of a marketed drug. These studies are usually phase 3, always well controlled, randomized, of adequate size and, whenever possible, double blind. May also be called Pivotal or Confirmatory Trials.
http://www.lillytrials.com/docs/terminology.html
More references:
http://tinyurl.com/kpeqvq2
Definition from Lilly's glossary:
Core Registration Studies: Those primary safety and efficacy studies that the relevant government health agency uses to decide whether or not to approve the investigational drug or new use of a marketed drug. These studies are usually phase 3, always well controlled, randomized, of adequate size and, whenever possible, double blind. May also be called Pivotal or Confirmatory Trials.
http://www.lillytrials.com/docs/terminology.html
More references:
http://tinyurl.com/kpeqvq2
Note from asker:
| Thank you, Natalie :) |
4 KudoZ points awarded for this answer.
Comment: "Thank you, Natalie, Igor and Olga."
+2
32 мин
registered clinical trial
Note from asker:
| Thank you, Allison. See my comment to Olga. |
Peer comment(s):
| agree |
cyhul
8 час
|
| agree |
Ravindra Godbole
9 час
|
| neutral |
Natalie
: registered study is not the same as registration study
16 час
|
53 мин
clinical trial for the purpose of a marketing authorization
регистрационное = в целях регистрации лекарственного средства (получения регистрационного удостоверения)
Clinical trial submitted in marketing authorisation application.
Clinical trial submitted in marketing authorisation application.
Example sentence:
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Note from asker:
| These two responses reflect my own confusion on the matter. I suspected that your suggestion is what is intended (though I wouldn't know how best to render it in English), but I am still not certain. Iwill wait for the votes to come in. Thank you, Olga. |
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