Bioequivalence and Bioavailability Forum 09:47 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Reference Listed Drug [Regulatives / Guidelines]

posted by ElMaestro - Denmark, 2017-04-19 09:43  - Posting: # 17252
Views: 2,789

Hi arpit.patel,

» Can we use difference batch of RLD in the single BE study.? Is there any guidance for such information.?

I have good experience with it (EU+US+Brazil). There are sometimes good reasons to do it, and sometimes no way around it. I am not aware of specific guidance.

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 17 (0 registered, 17 guests [including 12 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