Glossary entry (derived from question below)
Spanish term or phrase:
Periodo de validez
English translation:
shelf life
Added to glossary by
sebaspedlp
Dec 31, 2016 00:45
7 yrs ago
16 viewers *
Spanish term
Periodo de validez
Homework / test
Spanish to English
Medical
Medical: Pharmaceuticals
trabajo para facultad
6.3 Periodo de validez
24 meses.
6.4 Precauciones especiales de conservación
Consérvese en lugar fresco y protegido de la luz a temperatura no mayor a 25º C.
6.5 Naturaleza y contenido del recipiente
Podría ser ¿Shelf-life? o ¿validity period?
http://www.proz.com/kudoz/spanish_to_english/medical_general...
http://www.proz.com/kudoz/spanish_to_english/medical_pharmac...
es la descripción de un medicamento el resumen de como fue realizado
He leído esto entre otras cosas pero sigo sin entender cuál sería la correcta, muchas gracias
24 meses.
6.4 Precauciones especiales de conservación
Consérvese en lugar fresco y protegido de la luz a temperatura no mayor a 25º C.
6.5 Naturaleza y contenido del recipiente
Podría ser ¿Shelf-life? o ¿validity period?
http://www.proz.com/kudoz/spanish_to_english/medical_general...
http://www.proz.com/kudoz/spanish_to_english/medical_pharmac...
es la descripción de un medicamento el resumen de como fue realizado
He leído esto entre otras cosas pero sigo sin entender cuál sería la correcta, muchas gracias
Proposed translations
(English)
4 +3 | shelf life | Barbara Cochran, MFA |
4 | validity period/approval duration | Muriel Vasconcellos |
Proposed translations
+3
37 mins
Selected
shelf life
Agree with one of your interpretations.
Note from asker:
Thank you so much |
4 KudoZ points awarded for this answer.
Comment: "Thank you so much! Happy new year!"
1 hr
validity period/approval duration
If it's followed by a date, we say 'expiry/expiration date' or 'valid until', but since it's expressed in months, then it's 'validity period' in pharmaceutical terminology.
'Shelf life' is vague; it's what you would see on a loaf of bread. Here you're talking about the approval process and the period for which the drug is approved and allowed to be sold.
See: http://www.linguee.com/english-spanish/search?source=auto&qu...
Examples:
About 168,000 results (0.32 seconds)
Search Results
Frequently Asked Questions Injectable Drug Program - Moda Health
https://www.modahealth.com/pdfs/faq_injectables.pdf
For drugs other than those included on posted list, prior authorization requirements and .... The **approval duration or validity **depends on the medication.
https://www.ncbi.nlm.nih.gov/pubmed/16460606
by I De Giorgi - 2005 - Cited by 2 - Related articles
**Sterility validity period of vials** after multiple sampling under vertical laminar ... Drug Packaging/methods; Drug Packaging/standards*; Environmental Monitoring/ ...
https://books.google.com/books?isbn=1420020021
Isadore Kanfer, Leon Shargel - 2016 - Medical
If any drug does not fall under the ambit of a new drug, licenses could be issued by the state licensing authority. ... **Increased validity period of license**. 3.
Registration renewal of imported drugs (incl. pharmaceutical products ...
eng.sfda.gov.cn › Home › Regulatory Guide
I. Project name: Imported Drug Registration. II. ... Copies of "Imported Drug Registration Certificate" or "Pharmaceutical .... (4) **Shortened validity period of drugs**;
'Shelf life' is vague; it's what you would see on a loaf of bread. Here you're talking about the approval process and the period for which the drug is approved and allowed to be sold.
See: http://www.linguee.com/english-spanish/search?source=auto&qu...
Examples:
About 168,000 results (0.32 seconds)
Search Results
Frequently Asked Questions Injectable Drug Program - Moda Health
https://www.modahealth.com/pdfs/faq_injectables.pdf
For drugs other than those included on posted list, prior authorization requirements and .... The **approval duration or validity **depends on the medication.
https://www.ncbi.nlm.nih.gov/pubmed/16460606
by I De Giorgi - 2005 - Cited by 2 - Related articles
**Sterility validity period of vials** after multiple sampling under vertical laminar ... Drug Packaging/methods; Drug Packaging/standards*; Environmental Monitoring/ ...
https://books.google.com/books?isbn=1420020021
Isadore Kanfer, Leon Shargel - 2016 - Medical
If any drug does not fall under the ambit of a new drug, licenses could be issued by the state licensing authority. ... **Increased validity period of license**. 3.
Registration renewal of imported drugs (incl. pharmaceutical products ...
eng.sfda.gov.cn › Home › Regulatory Guide
I. Project name: Imported Drug Registration. II. ... Copies of "Imported Drug Registration Certificate" or "Pharmaceutical .... (4) **Shortened validity period of drugs**;
Note from asker:
Thank you! |
Peer comment(s):
neutral |
Andy Watkinson
: Several of your references would appear to be used when referring to licence/license validity periods. Not the same.
55 mins
|
Only one of the four refers to the license.
|
Reference comments
2 hrs
Reference:
FDA - Shelf life
The best way to verify long-term stability would be to stockpile supplies, let them sit for years, and even decades, and then test them. My American colleagues can thank their government for doing just such testing- the Department of Defense/FDA Shelf Life Extension Program has been in place for over 20 years.
https://sciencebasedmedicine.org/the-drug-expiry-date-a-nece...
Again, FDA:
On the Shelf Life of Pharmaceutical Products
https://www.ncbi.nlm.nih.gov › NCBI › Literature › PubMed Central (PMC)
by R Capen - 2012 - Cited by 12 - Related articles
Jun 23, 2012 - Since 1979, the Food and Drug Administration (FDA) has required that all prescription drugs have a shelf life (or expiration date) indicated ...
https://sciencebasedmedicine.org/the-drug-expiry-date-a-nece...
Again, FDA:
On the Shelf Life of Pharmaceutical Products
https://www.ncbi.nlm.nih.gov › NCBI › Literature › PubMed Central (PMC)
by R Capen - 2012 - Cited by 12 - Related articles
Jun 23, 2012 - Since 1979, the Food and Drug Administration (FDA) has required that all prescription drugs have a shelf life (or expiration date) indicated ...
Note from asker:
Thank you so much! HAppy new year!! |
6 hrs
Reference:
EMA templates
Your text does look like a medicinal product information based on the templates from the European Medicines Agency EMA. Their templates are available in all European languages on http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation... and are binding for all marketing authorization applications and procedures.
(Scroll down and select "QRD product-information template version 10" in the language of your choice from the drop-down menu).
(Scroll down and select "QRD product-information template version 10" in the language of your choice from the drop-down menu).
Note from asker:
Thank you so much! Very helpful!! Appreciate your help!! Happy new year! |
Peer comments on this reference comment:
agree |
Robert Carter
: Thanks for your insight, Anne, happy new year!
11 hrs
|
Thank you Robert, happy new year to you, too!
|
7 hrs
Reference:
More on "shelf life"
"Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
[...]
4. Use of terms
The following working definitions or explanations are offered for a number of the terms used in this text. [...]
Shelf-life (expiration dating period or validity period): The period of time during which a drug product is expected, if stored correctly, to remain within specification as determined by stability studies on a number of batches of the product. The shelf-life is used to establish the expiry date of each batch."
http://apps.who.int/medicinedocs/en/d/Jh1813e/3.2.4.html
"UNICEF
Technical Requirements for Pharmaceutical Products
[...]
Shelf life and Storage
1. The assigned shelf life and recommended storage conditions should reflect the outcome of stability studies, as per WHO guidelines and be printed on labels and leaflets. Acceptable temperature excursions should be specified."
https://www.unicef.org/french/supply/files/UNICEF_Technical_...
I think either "shelf life" or "validity period" would be acceptable.
[...]
4. Use of terms
The following working definitions or explanations are offered for a number of the terms used in this text. [...]
Shelf-life (expiration dating period or validity period): The period of time during which a drug product is expected, if stored correctly, to remain within specification as determined by stability studies on a number of batches of the product. The shelf-life is used to establish the expiry date of each batch."
http://apps.who.int/medicinedocs/en/d/Jh1813e/3.2.4.html
"UNICEF
Technical Requirements for Pharmaceutical Products
[...]
Shelf life and Storage
1. The assigned shelf life and recommended storage conditions should reflect the outcome of stability studies, as per WHO guidelines and be printed on labels and leaflets. Acceptable temperature excursions should be specified."
https://www.unicef.org/french/supply/files/UNICEF_Technical_...
I think either "shelf life" or "validity period" would be acceptable.
Note from asker:
Thank you so much for your help! Happy new year! |
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