Rana jaouni

2020-03-18 20:37
(149 d 02:42 ago)

Posting: # 21285
Views: 2,948

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

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.

Vienna, Austria,
2020-03-18 20:46
(149 d 02:32 ago)

@ Rana jaouni
Posting: # 21286
Views: 1,526

 RLD batch number in fed and fast studies

Hi Rana,

of course, you could. See this recent thread.

Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
 Admin contact
21,026 posts in 4,382 threads, 1,460 registered users;
online 22 (0 registered, 22 guests [including 16 identified bots]).
Forum time: Saturday 00:19 CEST (Europe/Vienna)

It has yet to be proven
that intelligence has any survival value.    Arthur C. Clarke

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