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relaxed upper bound

Russian translation: ослабленная верхняя граница

18:39 Jul 4, 2017
English to Russian translations [PRO]
Mathematics & Statistics
English term or phrase: relaxed upper bound
In response to proposed equivalence margins of ±13% (90% power with planned sample size of N=614 total), the Agency recommended (letter dated 08 April 2015) that the similarity margin for ACR20 response rates in the proposed CCS (comparative clinical study) in RA be set at ±12%, and that the type I error rate of a test of similarity be controlled at 1-sided 5%.

The Agency further noted that they would consider a proposal for a relaxed upper bound as part of an asymmetric similarity margin.

In response, we sought Agency’s comments on a proposed asymmetric margin of (-12%, +15%) for the similarity assessment in the CCS which was subsequently accepted. on Sept 15, 2015 along with a 90% CI for the difference in ACR 20 response rates at Week 14 to justify for the similarity assessment in B5371002 comparative clinical study.

The following subsections outline the justification for the proposed asymmetric margin.
Maxim Polukhin
Local time: 01:32
Russian translation:ослабленная верхняя граница
Explanation:
*
Selected response from:

sas_proz
Russian Federation
Local time: 01:32
Grading comment
Спасибо!
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1ослабленная верхняя граница
sas_proz
4пониженная верхняя граница
mk_lab


  

Answers


30 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
ослабленная верхняя граница


Explanation:
*

sas_proz
Russian Federation
Local time: 01:32
Specializes in field
Native speaker of: Russian
PRO pts in category: 70
Grading comment
Спасибо!

Peer comments on this answer (and responses from the answerer)
agree  Nik-On/Off
47 mins
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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
пониженная верхняя граница


Explanation:
Т.е., предлагается понизить верхнюю границу подобия

mk_lab
Ukraine
Local time: 01:32
Works in field
Native speaker of: Native in RussianRussian, Native in UkrainianUkrainian
PRO pts in category: 296
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