US FDA guidance [Bioanalytics]

posted by chandru – India, 2018-05-27 21:41 (1339 d 23:52 ago) – Posting: # 18820
Views: 2,782

Hi thank you all for your valuable inputs.

After the release of FDA guidance May 2018, is it mandatory to evaluate stability of molecule in presence of potentially interfering substance?

Is it mandatory to evaluate for all the concomitant medication given to subjects in a particular study or is it ok if we do it for regularly administered drug(eg., Some defined 10 drugs, putting in the SOP and evaluating it) ?


Complete thread:

 Admin contact
21,854 posts in 4,573 threads, 1,554 registered users;
online 13 (0 registered, 13 guests [including 11 identified bots]).
Forum time: Wednesday 20:33 CET (Europe/Vienna)

The real purpose of the scientific method is to make sure
nature hasn’t misled you into thinking you know something
you actually don’t know.    Robert M. Pirsig

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