Glossary entry

German term or phrase:

Haltbarkeitsdaten

English translation:

shelf-life data

Added to glossary by RNolder (X)
Nov 14, 2004 23:02
19 yrs ago
German term

Haltbarkeitsdaten

German to English Science Medical: Pharmaceuticals research- see previous questions
Ein Teil der Haltbarkeitsdaten der 200 mg-Tablette muß ggfs. als letzter Baustein in die IND eingefügt werden. AQ hat auch in dieser Hinsicht praktische Kooperation zugesagt.

Shelf-life data? Looking for specific medical term.

Discussion

Non-ProZ.com Nov 14, 2004:
This is why I asked the question. I already had checked the glossaries, etc. and did not find any medical/pharmaceutical references.
Non-ProZ.com Nov 14, 2004:
I think you are right sarmb! Why would only a part of the expiration dates or best-before dates be included as the final component in the IND?

Proposed translations

+5
11 mins
Selected

shelf-life data

Am J Hosp Pharm. 1986 Jun;43(6):1425, 1428. Shelf-life data for frozen premixed antimicrobials. Marsh DA. Publication Types Letter ...
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve& db=PubMed&list_uids=3728474&dopt=Abstract

Shelf-life data, Shelf life data as per existing guidelines in support of shelf life claim should be submitted. NR, R. 7. Method of analysis, ...
cibrc.nic.in/check6.htm - 16k

... 9. Analytical test report, R, R. 10. Shelf-life claim, R, R. 11. Shelf-life data, NR, R. B. BIO-EFFICACY, 1. Bio-effectiveness, R, R. 2. Phytotoxicity, R, R. ...
cibrc.nic.in/check2.htm - 8k

... If the manufacturer, importer, or repackager can document that the shelf-life data from a previously tested product is also applicable to a new, non-tested ...
www.fda.gov/cdrh/ode/1355.html - 34k

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Note added at 20 mins (2004-11-14 23:22:56 GMT)
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My guess is, we are talking about data here and not dates!
Peer comment(s):

agree Gisela Greenlee : I read this again and realized that it asked for "Daten", not "Datum", so your answer is most likely correct.
34 mins
Thanks
agree Kim Metzger : Makes sense.
1 hr
Thanks
agree sonja29 (X)
2 hrs
agree tnkw (X) : 'Shelf-life' is the term used in the official EMEA SPC template. (Section 6.3)
10 hrs
agree Gabrielle Lyons
10 hrs
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "Thank you all for the help"
+4
3 mins

best-before dates

Declined
Peer comment(s):

agree Susanne Rindlisbacher
2 mins
agree T. Czibulyás
3 mins
agree Dr.G.MD (X)
3 mins
agree roneill
3 mins
Something went wrong...
+3
8 mins

expiration date

Declined
See example below:
Explanation of Symbols Symbol Explanation Expiry Date Haltbarkeitsdatum
In Vitro ... carefully sealed in the plastic bag until the expiration date IL-1â ...
www.milenia-biotec.de/pdf/ immunologie/interleukine/IL-1b-mkl1-E.pdf - Similar pages
Peer comment(s):

agree Jonathan MacKerron : confirmed by GCP
8 mins
agree Ana Krämer
32 mins
agree gangels (X)
2 hrs
Something went wrong...
+1
9 mins

expiration dates

Declined
is another possibility
Shelf Life - Expiration Date. ... On the other hand, products stored under ideal conditions may be acceptable long after the expiration date has been reached. ...
vm.cfsan.fda.gov/~dms/cos-207.html - 5k
Peer comment(s):

agree roneill
6 mins
Something went wrong...
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