Subject outlier for pass study (FDA) [Outliers]
Dear All,
One BA/BE study was meeting acceptance criteria as per FDA retirement. (80-125%). IS this required to check outlier for pass bio-study?
Also if we apply outlier test for bio-study than one subject found as outlier and after excluding that subject, study goes to fail to meet acceptance criteria (80-125).
Please suggest
Thanks,
Kaushal
Edit: Subject line changed. [Helmut]
One BA/BE study was meeting acceptance criteria as per FDA retirement. (80-125%). IS this required to check outlier for pass bio-study?
Also if we apply outlier test for bio-study than one subject found as outlier and after excluding that subject, study goes to fail to meet acceptance criteria (80-125).
Please suggest
Thanks,
Kaushal
Edit: Subject line changed. [Helmut]
Complete thread:
- Subject outlier for pass study (FDA)kaushal09 2012-03-17 07:19
- Outlier testing in nonreplicate studies Helmut 2012-03-17 13:43