Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-07-23 02:05 CEST (UTC+2h)

What's the problem? [Regulatives / Guidelines]

posted by kumarnaidu - Mumbai, India, 2017-07-11 14:43  - Posting: # 17533
Views: 6,513

Hi all,
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:

Kumar Naidu

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,547 posts in 3,941 threads, 1,190 registered users;
online 11 (0 registered, 11 guests [including 11 identified bots]).

[The] impatience with ambiguity can be criticized in the phrase:
absence of evidence is not evidence of absence.    Carl Sagan

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