US FDA guidance [Bioanalytics]

posted by chandru – India, 2018-05-27 23:41 (1947 d 17:50 ago) – Posting: # 18820
Views: 3,085

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:

UA Flag
 Admin contact
22,761 posts in 4,775 threads, 1,628 registered users;
22 visitors (0 registered, 22 guests [including 6 identified bots]).
Forum time: 17:31 CEST (Europe/Vienna)

Whenever a theory appears to you as the only possible one,
take this as a sign that you have neither understood the theory
nor the problem which it was intended to solve.    Karl R. Popper

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