Bioequivalence and Bioavailability Forum

Hi dinesh,

so the elevated value is:

1. 3times the upper limit, and
   
2. consistent within the subject.

You must distinguish between two cases:

1. the subject was erroneously included -> that's a protocol deviation
   
2. the subject was intentionally included
   1. was rated as 'not clinical significant' by the investigator in the CRF/lab. prinout: everything should be fine (it's the personal/professional responsibility of the investigator)
      
   2. was not rated 'ncs': should be corrected during the review of original data (dated and signed by the investigator)

The post-study value must be rated as 'not clinical significant' as well, because 'clinical significant' abnormal values should have been commented by the investigator, must have been documented as an adverse event and generally would trigger a follow-up exam.

For potential explanations see my first post, but I'm not a medical doctor/physician - you should talk with a specialist for laboratory medicine/clinical chemistry.