RLD batch number in fed and fast studies [Regulatives / Guidelines]

posted by Rana jaouni – Jordan, 2020-03-18 20:37 (831 d 07:40 ago) – Posting: # 21285
Views: 3,488

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 the used batch may become expired Before we can conduct the fed pivotal study due to COVID-19 situation.

Please advise will the studies be acceptable by the US FDA, European and Brazil authorities?


Thanks in advance.


Regards
Rana

Complete thread:

UA Flag
Activity
 Admin contact
22,178 posts in 4,646 threads, 1,571 registered users;
online 11 (0 registered, 11 guests [including 4 identified bots]).
Forum time: Tuesday 05:18 CEST (Europe/Vienna)

It is futile to do with more things
that which can be done with fewer.    William of Ockham

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5