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  3. Medical: Pharmaceuticals

регистрационное клиническое исследование

English translation: Registration Study

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Russian term or phrase:регистрационное клиническое исследование
English translation:Registration Study
Entered by: Judith Hehir

16:57 Jul 24, 2013
Russian to English translations [PRO]
Medical - Medical: Pharmaceuticals / type of study
Russian term or phrase: регистрационное клиническое исследование
Регистрационное клиническое исследование III фазы

This appears under Вид исследования.

Thank you.
Judith Hehir
United States
Local time: 01:37
Registration Study
Explanation:
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

Selected response from:

Natalie
Poland
Local time: 07:37
Grading comment
Thank you, Natalie, Igor and Olga.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2Registration Study
Natalie
3 +2registered clinical trial
Allison Keating
3clinical trial for the purpose of a marketing authorization
Olga Avdeeva


  

Answers


32 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
registered clinical trial


Explanation:
http://en.wikipedia.org/wiki/Clinical_trials_registry

Allison Keating
Canada
Local time: 22:37
Native speaker of: English
Notes to answerer
Asker: Thank you, Allison. See my comment to Olga.


Peer comments on this answer (and responses from the answerer)
agree  cyhul
8 hrs
agree  Ravindra Godbole
9 hrs
neutral  Natalie: registered study is not the same as registration study
16 hrs
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53 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
clinical trial for the purpose of a marketing authorization


Explanation:
регистрационное = в целях регистрации лекарственного средства (получения регистрационного удостоверения)
Clinical trial submitted in marketing authorisation application.

Example sentence(s):
  • -
  • -
Olga Avdeeva
Russian Federation
Local time: 08:37
Specializes in field
Native speaker of: Russian
PRO pts in category: 64
Notes to answerer
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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2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
Registration Study


Explanation:
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



Natalie
Poland
Local time: 07:37
Specializes in field
Native speaker of: Russian
PRO pts in category: 712
Grading comment
Thank you, Natalie, Igor and Olga.
Notes to answerer
Asker: Thank you, Natalie :)


Peer comments on this answer (and responses from the answerer)
agree  Igor_2006
10 hrs
  -> Спасибо!
agree  Olga Avdeeva: Да, и правда, ведь пишут же *registration stability*, *registration dossier*, а мне показалось сначала, что слово *registration* будет неправильно восприниматься.
15 hrs
  -> Спасибо!
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