BE criteria [Regulatives / Guidelines]

posted by jag009  – NJ, 2018-08-06 22:35 (2231 d 00:55 ago) – Posting: # 19156
Views: 3,649

Hi,

❝ I prepared protocol for XX drug and when at the time of protocol preparation based on supportive...


Is the NTI criteria stated in the BE guidance for XX drug or there is no BE guidance from OGD?
You need a note to file saying the wrong analysis was carried out. Why you want to amend the protocol since you have literatures to support that XX drug is NTI and the protocol states that analysis be carried out based on NTI criteria.

John

Complete thread:

UA Flag
Activity
 Admin contact
23,225 posts in 4,879 threads, 1,652 registered users;
39 visitors (0 registered, 39 guests [including 8 identified bots]).
Forum time: 23:31 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

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