Bioequivalence and Bioavailability Forum

Hi dinesh,

I assume you are talking about alanine aminotransferase in serum (aka SGPT - serum glutamic-pyruvic transaminase)

What is your reference range (different for females/males and the method used)? - 120 U/l is about 2 - 4 times the upper limit.

Below the reference ranges [U/l] from three of our contract laboratories:
<31, 10-35,  5-38 (females)
<41, 10-50, 10-50 (males)
The result should be assessed in synopsis with other liver enzymes (e.g., ALP, AST); besides liver injury (e.g., chronic hepatitis) strenuous excercise may also increase ALT levels.
Are there other results from previous screenings available? The reference range includes 95% of the population, maybe the subject has a history of elevated values...
A single deviation may be assessed as not clinically significant by the investigator.
What was the result in the post-study evaluation?

If the volunteer was erroneously included in the study, you must report it as a protocol deviation and discuss the relevance on the outcome of the study (see above).