Use of 96.7% CI instead of 90% CI [Regulatives / Guidelines]
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
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
Complete thread:
- Use of 96.7% CI instead of 90% CIpjs 2015-07-08 17:07 [Regulatives / Guidelines]
- Use of 96.7% CI instead of 90% CI ElMaestro 2015-07-08 17:29
- Bonferroni (three tests) Helmut 2015-07-09 00:43
- Bonferroni (three tests) pjs 2015-07-09 09:11
- Bonferroni (three tests) Helmut 2015-07-09 12:18
- Bonferroni (three tests) pjs 2015-07-09 09:11