PE outside the acceptance range [Study As­sess­ment]

posted by aanrin – United Arab Emirates, 2015-07-27 14:27 (3483 d 17:15 ago) – Posting: # 15153
Views: 9,887

Hi

As per the regulatory requirements and guidelines for modified release tablet both fasting and fed study is recommended (MHRA, USFDA etc).

Regulatory agency - MHRA UK, canada, MOH UAE. will they accept the study if fasting meets the criteria and the fed study fails.

Complete thread:

UA Flag
Activity
 Admin contact
23,376 posts in 4,912 threads, 1,667 registered users;
203 visitors (0 registered, 203 guests [including 14 identified bots]).
Forum time: 06:42 CET (Europe/Vienna)

The great tragedy of Science – the slaying
of a beautiful hypothesis by an ugly fact.    Thomas Henry Huxley

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