Bioequivalence and Bioavailability Forum 15:18 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

What's the problem? [Regulatives / Guidelines]

posted by ElMaestro - Denmark, 2017-07-11 14:56  - Posting: # 17534
Views: 13,362

» 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 :-)

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,914 posts in 4,036 threads, 1,283 registered users;
online 5 (0 registered, 5 guests [including 4 identified bots]).

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

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