Chinese to English translations [PRO] Law/Patents - Law: Patents, Trademarks, Copyright | | Chinese term or phrase: 受理标准 | | 参见规范性文件 国药监械[2002]18号 受理标准 |
| | | Application Acceptance | Explanation: It's about a regulatory document concerning application acceptance.
The word 标准 must not be translated, because it must be clear in the document that the rules in it shall be observed and obeyed.
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Auf deutsch, Annahmerichtlinien. |
| Selected response from: Wenjer Leuschel Taiwan Local time: 07:58
| Grading comment Sehr hilfreich! 4 KudoZ points were awarded for this answer |
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| Discussion entries: 0 |
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Automatic update in 00:
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3 hrs confidence:  
4 hrs confidence:  peer agreement (net): +2 | 受理标准 acceptance criteria
Explanation: Used in connection with FDA filing for medicine and admission of trial participants in clinical trials.
http://www.actmagazine.com/appliedclinicaltrials/data/articl... criteria
admission criteria :
Basis for selecting target
population for a clinical trial. Subjects must
be screened to ensure that their characteristics
match a list of admission criteria and
that none of their characteristics match any
single one of the exclusion criteria set up
for the study. See also inclusion criteria.
Also for admission of a drug application file
-------------------------------------------------- Note added at 4 hrs 42 mins (2004-06-02 12:23:38 GMT) --------------------------------------------------
admission criteria for participating in clinical trials, but for files
http://www.fda.gov/cber/gdlns/frich122900.pdf
-------------------------------------------------- Note added at 4 hrs 47 mins (2004-06-02 12:28:34 GMT) --------------------------------------------------
http://www.fda.gov/cber/gdlns/ichtest.pdf
http://www.fda.gov/cder/regulatory/pet/present/cgmpvan/sld02...
>>The FDA is using \"acceptance criteria\".
| Marc Van Gastel Local time: 00:58 Specializes in field Native speaker of: Dutch
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