Oct 18, 2020 17:57
3 yrs ago
23 viewers *
Japanese term
United Kingdom
検証項目
Japanese to English
Medical
Medical: Pharmaceuticals
Hi all, I have encountered this term in a document describing the results of a large study. The context is similar to this:
https://www.amel-di.com/medical/di/download?type=21&pid=1423...
In the document I am translating, 検証項目 is written in parentheses after both the primary endpoint and some, but not all of the secondary endpoints.
Could this indicate the "confirmatory" endpoints? (As opposed to "exploratory")
Thank you in advance!
https://www.amel-di.com/medical/di/download?type=21&pid=1423...
In the document I am translating, 検証項目 is written in parentheses after both the primary endpoint and some, but not all of the secondary endpoints.
Could this indicate the "confirmatory" endpoints? (As opposed to "exploratory")
Thank you in advance!
Proposed translations
(English)
| 3 | validation item |
Reiko Ando
|
Proposed translations
4 hrs
Reiko Ando
United States
United States
Native in Japanese
Works in field
United States
Japanese-English Translator
Native in: Japanese 
Works in: Japanese to English, English to Japanese
Related KudoZ points
:
4
Selected
validation item
I think the item with（検証項目） in the endpoint means that the item is also an item that requires validation tests, which are test items testing possibly other than safety and efficacy.
https://www.fda.gov/files/drugs/published/Analytical-Procedu...
https://www.fda.gov/files/drugs/published/Analytical-Procedu...
4 KudoZ points awarded for this answer.
Comment: "Thanks, I went with this :) "
Reference comments
4 hrs
Reference:
FYR
https://www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?...
https://chikennavi.net/yougo/word/k/kenshouteki-shiken.htm
https://chikennavi.net/yougo/word/k/kenshouteki-shiken.htm
Note from asker:
| Thanks for these, helpful as always! |
Discussion
https://www.amgen.co.jp/-/media/Themes/CorporateAffairs/amge...