What's the problem? [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2017-07-11 14:56  – Posting: # 17534
Views: 17,089

» Recently we did pilot and pivotal (Partial reference replicate) studies for WHO and we got high variability (CV=32%). In the USFDA product specific guidance they have suggested 2x2 crossover design for this drug. Based on our prior experience can we perform reference replicate study or need to go as per guidance?:confused:

You probably have both options available. However, the gain with CV=32% is minute; I mean if you have a CVr of 32% in a replicate study you are widening the limits so minutely that I think it isn't worth the effort. At the end of the day those (semi)replicated are still far less routine than the standard 222BE jobs. And IEC's can have a lot of funny ideas when they review your protocol etc.

That said, I'd like to know the background better before saying this is my final answer :-)

I could be wrong, but...
Best regards,
ElMaestro

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,604 posts in 4,158 threads, 1,340 registered users;
online 9 (0 registered, 9 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 17:48 CEST

Nothing in the world is more dangerous
than sincere ignorance
and conscientious stupidity.    Martin Luther King, Jr.

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5