US FDA guidance [Bioanalytics]

posted by chandru – India, 2018-05-27 21:41 (1285 d 20:23 ago) – Posting: # 18820
Views: 2,757

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) ?

Regards,
Chandru

Complete thread:

Activity
 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 16 (0 registered, 16 guests [including 3 identified bots]).
Forum time: Friday 17:04 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

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