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postmarking setting

Russian translation: -

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:-
Russian translation:-
Entered by: Natalie
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17:46 Aug 25, 2008
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals / клинические испытания
English term or phrase: postmarking setting
there are risk minimization actions additional to labeling in the postmarking setting
Речь идет о идентифицированных рисках препарата.
Вот что еще нашла для информации:Phase IV Studies
Goal: These are *postmarking studies* and can have quite varied designs.
The purpose is usually to support the marketing campaign.
• These studies are generally done in the same target population as the original studies
that established the indication.
• If the study is done with the goal of submitting for a new indication, then it is usually
considered a phase II or III study even though the drug is already marketed
Alina Barrow
France
Local time: 08:00
typo: should be "postmarkETing setting"...
Explanation:
s

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Note added at 12 mins (2008-08-25 17:58:30 GMT)
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Adverse Events in the Postmarketing Setting .... http://www.fda.gov/medwatch/. 1-800-FDA-1088.
www.fda.gov/OHRMS/DOCKETS/ac/01/slides/3746s_02_shaffer_rev...

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Note added at 16 mins (2008-08-25 18:02:27 GMT)
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Two reports of hemolytic anemia were observed **in clinical trials**. Additional cases were reported **in the postmarketing setting**...
http://www.rxlist.com/cgi/generic/raptiva_ad.htm

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Note added at 23 mins (2008-08-25 18:09:41 GMT)
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"postmarketing studies" = "постмаркетинговые исследования";
"postmarketing setting" = возможно, "в условиях постмаркетинговых исследований" или "на этапе постмаркетинговой разработки"...
Selected response from:

Stanislav Korobov
Ukraine
Local time: 09:00
Grading comment
Спасибо!
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +1typo: should be "postmarkETing setting"...
Stanislav Korobov
1 -1постмаркетинговый периодLeila Usmanova


  

Answers


9 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
typo: should be "postmarkETing setting"...


Explanation:
s

--------------------------------------------------
Note added at 12 mins (2008-08-25 17:58:30 GMT)
--------------------------------------------------

Adverse Events in the Postmarketing Setting .... http://www.fda.gov/medwatch/. 1-800-FDA-1088.
www.fda.gov/OHRMS/DOCKETS/ac/01/slides/3746s_02_shaffer_rev...

--------------------------------------------------
Note added at 16 mins (2008-08-25 18:02:27 GMT)
--------------------------------------------------

Two reports of hemolytic anemia were observed **in clinical trials**. Additional cases were reported **in the postmarketing setting**...
http://www.rxlist.com/cgi/generic/raptiva_ad.htm

--------------------------------------------------
Note added at 23 mins (2008-08-25 18:09:41 GMT)
--------------------------------------------------

"postmarketing studies" = "постмаркетинговые исследования";
"postmarketing setting" = возможно, "в условиях постмаркетинговых исследований" или "на этапе постмаркетинговой разработки"...

Stanislav Korobov
Ukraine
Local time: 09:00
Meets criteria
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 1007
Grading comment
Спасибо!

Peer comments on this answer (and responses from the answerer)
agree  Pavel Venediktov: В период после регистрации препарата, т.е. после получения Marketing authorization/
1 hr
  -> Спасибо! Да, думаю, что Вы правы.

neutral  Angelika Kuznetsova: Я думаю, Павлу нужно запостить свой ответ
11 hrs
  -> Может, и нужно... Вы хотите, чтоб об этом его попросил я? :-)
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14 mins   confidence: Answerer confidence 1/5Answerer confidence 1/5 peer agreement (net): -1
постмаркетинговый период


Explanation:
Если верить толковому словарю:
Setting - the locale or period in which the action of a novel, play, film, etc., takes place: The setting of this story is Verona in the 15th century. http://dictionary.reference.com/browse/setting

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Note added at 11 час (2008-08-26 05:24:37 GMT)
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http://www.google.ru/search?num=20&complete=1&hl=ru&newwindo...

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Note added at 11 час (2008-08-26 05:44:43 GMT)
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Для Анжелики: period - одно из значений слова setting, согласно толковому словарю. - см. ссылку выше.

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Note added at 12 час (2008-08-26 05:55:52 GMT)
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Постмаркетинговый период = пострегистрационный период = IV фаза клинических испытаний:
http://www.provisor.com.ua/archive/1999/N18/phmarket.htm
"IV фаза клинических испытаний (постмаркетинговые, пострегистрационные исследования) — исследования на 2000–10000 человек и более. Проводятся при наличии регистрации лекарственного препарата и после начала его широкого применения. Проводится оценка терапевтической ценности лекарственного препарата, мониторинг побочных реакций и опасных взаимодействий с другими лекарственными препаратами, которые не были выявлены в III фазе клинических испытаний (фармаконадзор — pharmacovigilance).

Leila Usmanova
Local time: 09:00
Meets criteria
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 2493

Peer comments on this answer (and responses from the answerer)
disagree  Angelika Kuznetsova: А медицина где?:)
10 hrs
  -> setting - период, postmarketing setting - постмаркетинговый период. Что Вам непонятно в моем ответе ?
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Changes made by editors
Oct 20, 2008 - Changes made by Natalie:
Edited KOG entry<a href="/profile/697304">Stanislav Korobov's</a> old entry - "postmarking setting" » "typo: should be "postmarkETing setting" ("этап постмаркетинговых исследований")"
Aug 26, 2008 - Changes made by Stanislav Korobov:
Created KOG entryKudoZ term » KOG term


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