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development core safety information

Spanish translation: información básica sobre la seguridad

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:development core safety information
Spanish translation:información básica sobre la seguridad
Entered by: Paola Leaño
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21:20 Aug 30, 2010
English to Spanish translations [PRO]
Medical - Medical: Pharmaceuticals / clinical trials
English term or phrase: development core safety information
No more context, it's part of the table of contents. I have found what it is, but I'm still looking for a standard way to say it in spanish
Paola Leaño
United States
Local time: 23:14
información básica sobre la seguridad/toxicidad del producto en fase de investigación
Explanation:
Se denomina Development Core Safety Information (DCSI) la información relativa a la toxicidad de un medicamento en desarrollo que figura en el manual del investigador (investigator's (drug) brochure, clinical investigation brochure) de un ensayo clínico.

Si el fámaco en cuestión supera con éxito la fase de investigación clínica y se autoriza su comercialización, la DCSI constituye la base para la redacción de la Company Core Safety Information (DCSI) (información básica sobre la toxicidad/seguridad del producto).

Hoy en día, los laboratorios farmacéuticos prefieren utilizar el eufemismo "seguridad" (de un medicamento) para referirse a la toxicidad.

Saludos cordiales.

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Note added at 3 horas (2010-08-31 01:11:31 GMT)
--------------------------------------------------

Acá se explica claramente de qué se trata:

http://www.pharmiceutics.com/training-services/company-core-...
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_d...
http://books.google.com/books?id=t9PfXItFKHIC&pg=PA144&lpg=P...

--------------------------------------------------
Note added at 9 días (2010-09-09 10:00:46 GMT) Post-grading
--------------------------------------------------

De nada...
Selected response from:

M. C. Filgueira
Local time: 05:14
Grading comment
4 KudoZ points were awarded for this answer

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Summary of answers provided
5 +1información básica sobre la seguridad/toxicidad del producto en fase de investigaciónM. C. Filgueira
5 +1información básica de seguridad del desarrolloOtto Albers


  

Answers


1 hr   confidence: Answerer confidence 5/5 peer agreement (net): +1
información básica de seguridad del desarrollo


Explanation:
Since you specify that there is no more context, I assume that you are referring to the development of clinical trials in a health care environment, and that your inquiry refers to the basic safety measures to be adopted when carrying said trials.
Thus my target term has "desarrollo" as the subject, and "core safety information" as complement.

Otto Albers
Local time: 23:14
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in SpanishSpanish
PRO pts in category: 16

Peer comments on this answer (and responses from the answerer)
agree  María del Carmen Rodríguez Luna
20 mins

disagree  M. C. Filgueira: No se trata de la seguridad del desarrollo, sino de la seguridad --es decir, la toxicidad-- del producto en fase de investigación. Saludos cordiales.
2 hrs

agree  felicianomadrid
3 hrs
Login to enter a peer comment (or grade)

3 hrs   confidence: Answerer confidence 5/5 peer agreement (net): +1
información básica sobre la seguridad/toxicidad del producto en fase de investigación


Explanation:
Se denomina Development Core Safety Information (DCSI) la información relativa a la toxicidad de un medicamento en desarrollo que figura en el manual del investigador (investigator's (drug) brochure, clinical investigation brochure) de un ensayo clínico.

Si el fámaco en cuestión supera con éxito la fase de investigación clínica y se autoriza su comercialización, la DCSI constituye la base para la redacción de la Company Core Safety Information (DCSI) (información básica sobre la toxicidad/seguridad del producto).

Hoy en día, los laboratorios farmacéuticos prefieren utilizar el eufemismo "seguridad" (de un medicamento) para referirse a la toxicidad.

Saludos cordiales.

--------------------------------------------------
Note added at 3 horas (2010-08-31 01:11:31 GMT)
--------------------------------------------------

Acá se explica claramente de qué se trata:

http://www.pharmiceutics.com/training-services/company-core-...
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_d...
http://books.google.com/books?id=t9PfXItFKHIC&pg=PA144&lpg=P...

--------------------------------------------------
Note added at 9 días (2010-09-09 10:00:46 GMT) Post-grading
--------------------------------------------------

De nada...

M. C. Filgueira
Local time: 05:14
Specializes in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 1279

Peer comments on this answer (and responses from the answerer)
agree  Karla Rodríguez
2283 days
Login to enter a peer comment (or grade)




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Changes made by editors
Sep 9, 2010 - Changes made by M. C. Filgueira:
Field (specific)Medical: Health Care » Medical: Pharmaceuticals
Aug 30, 2010 - Changes made by Travelin Ann:
Language pairSpanish to English » English to Spanish


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