Abnormal lab parameters [Study Per­for­mance]

posted by suchit_bhavsar – India, 2011-03-04 12:31 (5183 d 11:01 ago) – Posting: # 6703
Views: 4,962

If in safety evaluation any laboratory parameter will be out of range then we will file AE for that correct.
Now my question is it will be consider as a post study period 2 AE or after completion of AE study ?
and what we will write in study medication ? Period 2 treatment or both the test and reference ?

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,670 registered users;
75 visitors (0 registered, 75 guests [including 39 identified bots]).
Forum time: 00:33 CEST (Europe/Vienna)

If you shut your door to all errors
truth will be shut out.    Rabindranath Tagore

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5