Expiration of Reference drug during Bioanalysis [Bioanalytics]

posted by jag009  – NJ, 2019-04-15 06:51 (1168 d 09:54 ago) – Posting: # 20160
Views: 4,679

Hi,

» I face a situation in the evaluation of a Bio-equivalence study which was conducted by a reference drug that was given to the subjects at the last month of it's shelf-life...

I had the issue 2 times before w FDA studies. As long as dosing is done there shouldn't be any issues. My studies completed dosing a week before the RLD expiry date.

J

Complete thread:

UA Flag
Activity
 Admin contact
22,170 posts in 4,645 threads, 1,570 registered users;
online 6 (1 registered, 5 guests [including 2 identified bots]).
Forum time: Sunday 16:45 CEST (Europe/Vienna)

The person interested in success has to learn
to view failure as a healthy, inevitable part
of the process of getting to the top.    Joyce Brothers

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