Clarity required [Regulatives / Guidelines]

posted by suchit_bhavsar – India, 2021-08-27 07:02 (916 d 17:21 ago) – Posting: # 22548
Views: 1,768

Dear All,

Hello to every one.

As per latest published draft guideline "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA", under heading Data deletion because of vomiting, one sentence is there like The concentration data for the subject who vomited should be reported

Hence it is required to report concentration data of subject who had vomited for the USFDA studies

Valuable suggestions required

Regards,
Suchit Bhavsar


Edit: Guidance linked. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
22,916 posts in 4,807 threads, 1,646 registered users;
31 visitors (0 registered, 31 guests [including 7 identified bots]).
Forum time: 23:23 CET (Europe/Vienna)

Nothing shocks me. I’m a scientist.    Harrison Ford (as Indiana Jones)

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