Use of 96.7% CI instead of 90% CI [Regulatives / Guidelines]

posted by pjs – India, 2015-07-08 19:07 (3504 d 00:37 ago) – Posting: # 15053
Views: 4,078

Dear all,

In One of the UKPAR, applicant had used 96.7% of CI instead of 90% CI. The comment from the agency was:

The applicant has provided suitable justification for the use of the adjusted confidence interval 96.7 % instead of a confidence limit 90%.

What could be the reason to use 96.7% CI (decreasing the patient risk ??? increasing the faith in product???)

and what justification would have been given.

Regards,
PJS

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