Mar 31, 2016 20:26
8 yrs ago
1 viewer *
English term

15K, 5K

English to Spanish Medical Medical (general) ensayos clínicos
Hola colegas, tengo estos números pero no tengo mucho contexto.

Solo que se habla de una escala a 15K... dejo el contexto:

TR03SDTM and TR03EDTM capture the initial/final doses for 15K product for those subjects who had 5K before transitioning onto 15K.

For most subjects, this will be 15K material.

Gracias
Proposed translations (Spanish)
4 +1 15 000/5000
4 15K and 5K
Change log

Mar 31, 2016 20:26: changed "Kudoz queue" from "In queue" to "Public"

Votes to reclassify question as PRO/non-PRO:

Non-PRO (2): Antonio Tomás Lessa do Amaral, abe(L)solano

When entering new questions, KudoZ askers are given an opportunity* to classify the difficulty of their questions as 'easy' or 'pro'. If you feel a question marked 'easy' should actually be marked 'pro', and if you have earned more than 20 KudoZ points, you can click the "Vote PRO" button to recommend that change.

How to tell the difference between "easy" and "pro" questions:

An easy question is one that any bilingual person would be able to answer correctly. (Or in the case of monolingual questions, an easy question is one that any native speaker of the language would be able to answer correctly.)

A pro question is anything else... in other words, any question that requires knowledge or skills that are specialized (even slightly).

Another way to think of the difficulty levels is this: an easy question is one that deals with everyday conversation. A pro question is anything else.

When deciding between easy and pro, err on the side of pro. Most questions will be pro.

* Note: non-member askers are not given the option of entering 'pro' questions; the only way for their questions to be classified as 'pro' is for a ProZ.com member or members to re-classify it.

Discussion

M. C. Filgueira Apr 3, 2016:
No Los ensayos clínicos de fase III se realizan con un gran número de pacientes y nada impide que el producto destinado a estos ensayos se fabrique en la planta comercial, con los mismos equipos que se utilizarán para fabricar el producto comercial.

En cuanto a los ensayos clínicos de fase IV, se realizan una vez que se ha obtenido la autorización de comercialización.

Por último, en la industria farmacéutica, cuando se habla de escalas de 5.000, 10.000, 15.000 litros, etc., los litros no son forzosamente de producto; si se trata de un producto biotecnológico (por ejemplo, un anticuerpo monoclonal) el volumen en cuestión suele ser el del fermentador de producción (es decir, el último de la etapa de cultivo celular).

Pero claro, sin mayor contexto, no se puede estar seguro de qué designan en este caso las abreviaturas 5K y 15K. También pueden referirse a comprimidos, viales, jeringas precargadas...
Neil Ashby Apr 3, 2016:
Surely if a product is at mass production stage (15 litres is a lot) it wouldn't still be undergoing clinical trials, it would have already passed them. A scale-up would be validated in the factory and by external production audits, but not in a clinical trial, no?
M. C. Filgueira Apr 2, 2016:
Además (ya me había olvidado)... ...el propio Mario dice: "Solo que se habla de una escala a 15K".
M. C. Filgueira Apr 2, 2016:
¡Pero claro que sí! Toda la información sobre el producto administrado cuenta en un ensayo clínico. Cuando se pasa de una escala de fabricación a otra todo debe ser validado.
Neil Ashby Apr 2, 2016:
The more I think about MC's comments the less sense they make. Why talk about production scale IN SHORTHAND, and without explaining what that shorthand means previously, when it's a clinical trial and not a production audit or QC validation?
What has the scale of production got to do with different patient groups? Why would a clinical trial be interested in whether a batch was made with 5,000 (presumedly) litres or 15,000 litres?
Please enlighten me with your logic, I don't get it!?
Neil Ashby Apr 2, 2016:
MC But what would that have to do with a clinical trial?
We don't have any English context about the asker's comment "escala a 15k" (I don't know why he said it without explaining it or putting the original English).
You're making a lot of leaps of faith and assumptions.
M. C. Filgueira Apr 1, 2016:
Escala de ... A todas luces están hablando de dos escalas de fabricación: 5.000 y 15.000 ¿litros, kilogramos,...? (Como se trata de un producto farmacéutico, deben ser probablemente litros.)

5K/15K product = producto fabricado a la escala de ... ("escala de...", y no "escala a...")

Los laboratorios farmacéuticos para los que trabajo suelen hablar de "escala de 5K" (o "5 K"), "escala de 10K" (o 10 K"), etc., y así se indica en los textos, con la expresión completa y la abreviatura entre paréntesis la primera vez que aparece; por ejemplo: escala de 5.000 litros (5 K).

Saludos cordiales.

Proposed translations

+1
13 mins

15 000/5000

¿Tu duda es por la letra"K"? Si es así, la letra "K" significa "mil".
Peer comment(s):

agree Paula Sabirón : Yo también lo entiendo así.
13 hrs
Gracias, Paula. Aunque evidentemente no era esa la duda de Mauro. ;)
Something went wrong...
12 hrs

15K and 5K

Looks like the name of two different products.
If not, I'd ask the client because there is no science behind just writing "15,000" and "5,000" [5,000 what? potatoes?, elephants? mg?] – without mentioning any units they're meaningless.
Something went wrong...
Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search