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producto en fase de investigación

English translation: New Drug Application

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:solicitud de consideración de producto en fase de investigación (PEI)
English translation:New Drug Application
Entered by: Gillian Hargreaves
Options:
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- Include in personal glossary

06:33 Dec 4, 2001
Spanish to English translations [PRO]
Medical
Spanish term or phrase: producto en fase de investigación
Solicitud de consideración de producto en fase de investigación (PEI)

This is the title of a registration document for a pharmaceutical product. I think that PEI should be translated as research product, but I'd be grateful for confirmation or correction, and also for suggestions for the whole phrase.
Gillian Hargreaves
Local time: 05:27
New Drug Application
Explanation:
En los EE.UU. los medicamentos en investigaciOn sometidos a evaluaciOn para aprobaciOn por la FDA (Food and Drug Administration) deben solicitar aprobaciOn por medio de una NDA (New Drug Application). Asi que "Solicitud de consideración de producto en fase de investigación (PEI)" se traduce como 'New Drug Application' y por ende se asume que el producto estA en fase de investigaciOn. Esto hace parte del lenguaje de GCP o "Good Clinical Practice" por el cual se guian hoy en dia, los laboratorios de investigaciOn en la realizaciOn de ensayos clinicos.
Saludos,
Selected response from:

osierra
Grading comment
Thanks very much Oscar (to all four of your replies!).
That's exactly what I needed to know.
4 KudoZ points were awarded for this answer

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Summary of answers provided
5New Drug Applicationosierra
5New Drug Applicationosierra
5Product under research
Irecu
5IND = investigational new drug
Nikki Graham
5New Drug Applicationosierra
5New Drug Applicationosierra
4 +1product in the research stage - product being researched / investigated
Robert INGLEDEW
5Product in phase of experimentation
Luciana Miquelino
4product under study / analysisTelesforo Fernandez
4Classification Request - Research Productcarpman22


  

Answers


14 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
Classification Request - Research Product


Explanation:
I agree with research product, and since the whole thing is a title, it doesn't necessarily haver to be gramaticall "pretty"...:)

carpman22
United Kingdom
Local time: 05:27
PRO pts in pair: 17
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16 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
product in the research stage - product being researched / investigated


Explanation:
I would use the first option.

Robert INGLEDEW
Argentina
Local time: 02:27
Native speaker of: Native in EnglishEnglish, Native in SpanishSpanish
PRO pts in pair: 1940

Peer comments on this answer (and responses from the answerer)
agree  Myrtha
58 mins
  -> Thank you.
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30 mins   confidence: Answerer confidence 5/5
Product in phase of experimentation


Explanation:
El producto está sendo investigado, en fase de teste.
Vea, en el sítio abajo:

remover has overcome severe tests in phase of experimentation and of control quality.




    Reference: http://www.omisan.com/sitengl/products/lineaoftyll/remover/d...
Luciana Miquelino
Brazil
Local time: 03:27
Native speaker of: Native in PortuguesePortuguese
PRO pts in pair: 8
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31 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
product under study / analysis


Explanation:
I would suggest 'product under study/ analysis'

Telesforo Fernandez
Local time: 10:57
PRO pts in pair: 262
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52 mins   confidence: Answerer confidence 5/5
New Drug Application


Explanation:
En los EE.UU. los medicamentos en investigaciOn sometidos a evaluaciOn para aprobaciOn por la FDA (Food and Drug Administration) deben solicitar aprobaciOn por medio de una NDA (New Drug Application). Asi que "Solicitud de consideración de producto en fase de investigación (PEI)" se traduce como 'New Drug Application' y por ende se asume que el producto estA en fase de investigaciOn. Esto hace parte del lenguaje de GCP o "Good Clinical Practice" por el cual se guian hoy en dia, los laboratorios de investigaciOn en la realizaciOn de ensayos clinicos.
Saludos,


    Reference: http://www.fda.gov/cber/efoi/nda.htm
osierra
PRO pts in pair: 36
Grading comment
Thanks very much Oscar (to all four of your replies!).
That's exactly what I needed to know.
Login to enter a peer comment (or grade)

54 mins   confidence: Answerer confidence 5/5
New Drug Application


Explanation:
En los EE.UU. los medicamentos en investigaciOn sometidos a evaluaciOn para aprobaciOn por la FDA (Food and Drug Administration) deben solicitar aprobaciOn por medio de una NDA (New Drug Application). Asi que "Solicitud de consideración de producto en fase de investigación (PEI)" se traduce como 'New Drug Application' y por ende se asume que el producto estA en fase de investigaciOn. Esto hace parte del lenguaje de GCP o "Good Clinical Practice" por el cual se guian hoy en dia, los laboratorios de investigaciOn en la realizaciOn de ensayos clinicos.
Saludos,


    Reference: http://www.fda.gov/cber/efoi/nda.htm
osierra
PRO pts in pair: 36
Login to enter a peer comment (or grade)

56 mins   confidence: Answerer confidence 5/5
New Drug Application


Explanation:
En los EE.UU. los medicamentos en investigaciOn sometidos a evaluaciOn para aprobaciOn por la FDA (Food and Drug Administration) deben solicitar aprobaciOn por medio de una NDA (New Drug Application). Asi que "Solicitud de consideración de producto en fase de investigación (PEI)" se traduce como 'New Drug Application' y por ende se asume que el producto estA en fase de investigaciOn. Esto hace parte del lenguaje de GCP o "Good Clinical Practice" por el cual se guian hoy en dia, los laboratorios de investigaciOn en la realizaciOn de ensayos clinicos.
Saludos,


    Reference: http://www.fda.gov/cber/efoi/nda.htm
osierra
PRO pts in pair: 36
Login to enter a peer comment (or grade)

58 mins   confidence: Answerer confidence 5/5
New Drug Application


Explanation:
En los EE.UU. los medicamentos en investigaciOn sometidos a evaluaciOn para aprobaciOn por la FDA (Food and Drug Administration) deben solicitar aprobaciOn por medio de una NDA (New Drug Application). Asi que "Solicitud de consideración de producto en fase de investigación (PEI)" se traduce como 'New Drug Application' y por ende se asume que el producto estA en fase de investigaciOn. Esto hace parte del lenguaje de GCP o "Good Clinical Practice" por el cual se guian hoy en dia, los laboratorios de investigaciOn en la realizaciOn de ensayos clinicos.
Saludos,


    Reference: http://www.fda.gov/cber/efoi/nda.htm
osierra
PRO pts in pair: 36
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3 hrs   confidence: Answerer confidence 5/5
Product under research


Explanation:
Es lo que más se ajusta a lo que estás traduciendo.
Saludos


    experiencia
Irecu
Local time: 02:27
Native speaker of: Native in SpanishSpanish
PRO pts in pair: 157
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18 hrs   confidence: Answerer confidence 5/5
IND = investigational new drug


Explanation:
Hi,
I saw your question yesterday, but had no time to answer. Hope it's not too late.
This question was asked a while back, and the above is what I suggested.
Hope you find the other ref useful too.
NDA (according to ref) can stand for new drug application/approval


    Reference: http://www.proz.com/?sp=h&eid_c=21787&id=103643&keyword=pei
    Reference: http://www.fda.gov/cder/regulatory/applications/ind_page_1.h...
Nikki Graham
United Kingdom
Local time: 05:27
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 5584
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