Glossary entry (derived from question below)
Spanish term or phrase:
seguimiento de estabilidad
English translation:
stability monitoring
Added to glossary by
sebaspedlp
Feb 6, 2016 21:08
8 yrs ago
13 viewers *
Spanish term
Argentina
Casi termino la carrera de Traductor
Native in: Spanish (Variant: Argentine) 
Works in: Spanish to English
seguimiento de estabilidad
Spanish to English
Medical
Medical: Pharmaceuticals
trabajo práctico faculta
Se realizó el seguimiento de la estabilidad sobre 3 lotes de producción.
monitoring of stability
follow up of stability
gracias
monitoring of stability
follow up of stability
gracias
Proposed translations
(English)
| 4 +2 | stability monitoring |
Robert Carter
|
| 5 +2 | stability monitoring |
Dr. Jason Faulkner
|
| 5 | stability testing |
Neil Ashby
|
| 4 | The stability [of 3 productiong batches] was monitored |
Muriel Vasconcellos
|
Proposed translations
+2
12 mins
Robert Carter
Mexico
Mexico
Native in English
Specializes in field
Mexico
Translating full-time since 1998
Native in: English (Variant: British) 
Works in: Spanish to English
Related KudoZ points
:
115
Selected
stability monitoring
Information to support the stability of the drug substance during the toxicologic studies and the proposed clinical study(ies) should include the following: a brief description of the stability study and the test methods used to monitor the stability of the drug substance and preliminary tabular
data based on representative material. Neither detailed stability data nor the stability protocol
need to be submitted.
http://www.fda.gov/ohrms/dockets/98fr/980362gd.pdf
In this case, I might change the word order:
"The stability of three production batches was monitored."
data based on representative material. Neither detailed stability data nor the stability protocol
need to be submitted.
http://www.fda.gov/ohrms/dockets/98fr/980362gd.pdf
In this case, I might change the word order:
"The stability of three production batches was monitored."
Note from asker:
| thank you !! |
4 KudoZ points awarded for this answer.
Comment: "Muchas gracias por la respuesta con la explicación, fue de mucha ayuda"
+2
11 mins
stability monitoring
SaludoZ!
Note from asker:
| thank you! |
Peer comment(s):
| agree |
Charles Davis
2 hrs
|
| agree |
liz askew
: I was thinking the wrong way round on this one!!
1 day 18 hrs
|
4 hrs
Muriel Vasconcellos
United States
United States
Native in English
Works in field
United States
Each translation a gem!
Native in: English (Variant: US)
Works in: Spanish to English, Portuguese to English
Related KudoZ points
:
267
The stability [of 3 productiong batches] was monitored
The phrase needs to fit with the rest of the sentence.
13 hrs
Neil Ashby
Spain
Spain
Native in English
Specializes in field
Spain
DrNeil TechTrans, Precision & Clarity
Native in: English
Works in: Spanish to English, English
Related KudoZ points
:
136
stability testing
Stability is measured over time and so "follow-up" or "monitoring" aren't necessary, simply "stability testing"; as per the EMEA
"European Medicines Agency
August 2003
CPMP/ICH/2736/99
ICH Topic Q 1 A (R2)
Stability Testing of new Drug Substances and Products
Step 5
NOTE FOR GUIDANCE ON STABILITY TESTING:
STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug ...
Q 1 A (R2) Stability Testing of new Drug Substances and ...
http://www.ema.europa.eu/docs/en_GB/document_library/Scienti...
"European Medicines Agency
August 2003
CPMP/ICH/2736/99
ICH Topic Q 1 A (R2)
Stability Testing of new Drug Substances and Products
Step 5
NOTE FOR GUIDANCE ON STABILITY TESTING:
STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug ...
Q 1 A (R2) Stability Testing of new Drug Substances and ...
http://www.ema.europa.eu/docs/en_GB/document_library/Scienti...
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