Glossary entry

Spanish term or phrase:

valoración del principio activo

English translation:

assay of the drug substance

Added to glossary by Micaela Pronsky (X)
Sep 22, 2011 13:12
12 yrs ago
7 viewers *
Spanish term

valoración del principio activo

Spanish to English Medical Medical: Pharmaceuticals
Descripción del método utilizado de valoración del principio activo
Valoración de clindamicina fosfato
Se emplea el método de valoración de Fosfato de Clindamicina descrito en la monografía

Discussion

Micaela Pronsky (X) (asker) Sep 26, 2011:
THANKS!
Emma Goldsmith Sep 24, 2011:
"principo activo": context is all-important For SPCs, PLs, labelling, etc. "principio activo" should be translated as "active substance" (following QRD for regulatory documents):
http://www.ema.europa.eu/docs/en_GB/document_library/Regulat...

However, for pharmaceutical texts, "drug substance" is the preferred term:

U S. Pharmacopeia:
The purpose of the Assay test is to quantify **drug substance** content
http://www.usp.org/pdf/EN/USPNF/chapter1.pdf

FDA:
In many cases it is possible to employ the same procedure (e.g., HPLC) for both assay of the new **drug substance** and quantitation of impurities.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma...

Note that "active ingredient" is not recommended any more (see first link).

Proposed translations

4 mins
Selected

assay of the drug substance

An assay determines the content of the drug substance

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Note added at 6 mins (2011-09-22 13:19:10 GMT)
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ICH-Q6A: Test Procedures and Acceptance Criteria for New Drug Substances
http://uqu.edu.sa/files2/tiny_mce/plugins/filemanager/files/...
c) Assay: A specific, stability-indicating procedure should be included to determine the content of the new drug substance


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Note added at 9 mins (2011-09-22 13:21:27 GMT)
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assay=valoración
http://www.proz.com/kudoz/english_to_spanish/medical:_pharma...
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4 KudoZ points awarded for this answer.
+2
17 mins

assay of the active pharmaceutical ingredient/substance

"The **assay** is based on the concentration-dependent variation of the inhibitory ... of the same **active pharmaceutical ingredient** (API) of the innovator, ..... (i.e. oral forms) or prodrugs (e.g. clindamycin phosphate) by our method"

http://www.biomedcentral.com/1472-6904/9/1

Regards, Marta.
Peer comment(s):

agree Neil Ashby : I agree but only with "....active substance", "active pharmaceutical INGREDIENT" is not a typical collocation in the UK
51 mins
Thanks DrNeil!! Remark appreciated.
agree philgoddard : Also, 'pharmaceutical' is unnecessary.
1 hr
Thanks Phil!! Also for your remark.
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1 hr

see answer below

Description of the method for "testing" the active ingredient.
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1 hr

evaluation of active ingredient

a pesar de que se puede usar "assay" por lo general la literatura sobre el tema utiliza más "evaluation"
ver http://www.labratjobs.com/job/6944/scientist/
Example sentence:

evaluation of the state of active ingredients in Pharmaceutical preparations

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6 hrs

Active Substance/Ingredient Assessment

El ensayo (Assay) es una entidad más compleja, en la que un apartado puede ser la valoración (Assessment)
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