Bioequivalence and Bioavailability Forum

Dear ^Such_it,

again: Please follow the Forum's Policy in the future - you have been notified numerous times.
Is it really that complicated to say “hello”‽

❝ If in safety evaluation any laboratory parameter will be out of range then we will file AE for that correct.

Yes.

❝ Now my question is it will be consider as a post study period 2 AE or after completion of AE study ?

I don’t know your SOPs. Most people would consider them as post study - but this is nitpicking, of course. I came only once across a case where lab evaluations (besides screening) were performed at hospitalizations and after both periods…

❝ and what we will write in study medication ? Period 2 treatment or both the test and reference ?

Any cross-over study should be designed in such a way that no residual effects of period 1 are substantial in period 2 (= no carry-over). Following this rationale you should code the AE to the treatment of period 2, IMHO.