Reference Listed Drug [Regulatives / Guidelines]

posted by kiranActimus – India, 2011-05-11 10:36  – Posting: # 7004
Views: 6,197

Dear All

Please suggest me whether we can do Fasting and Fed BE Studies of same Molecule with two different batches of RLD?

We have conducted fasting pivotal study with one batch of reference product but our client want to go with a different batch of reference product for the fed pivotal study due to unavailabilty of same batch of RLD used for fasting study.

Please advise will the studies be acceptable by the US FDA?


Thanks in advance.


Regards
Kiran

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,688 posts in 4,178 threads, 1,352 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 18:04 CEST

An expert is one who knows more and more
about less and less.    Nicholas Murray Butler

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