Mithu
☆    

India,
2019-09-30 07:42

Posting: # 20651
Views: 1,557
 

 SUPAC level 3 changes for MR formulations [Regulatives / Guidelines]

Dear All,

My questions are on SUPAC IR and MR guidance about the conduction of BE study due to change in manufacturing site change:

1. IR product if we change the manufacturing site, do we need to perform BE study as suggested in SUPAC guidance for IR? or it would be okay to justify based on in vitro data?
2. For MR product SUPAC MR guidance is not clear for any requirement of conducting BE study. where as we do perform Fasting for such changes in manufacturing site change. are we doing correct?

regards,

Mithu.
jag009
★★★

NJ,
2019-10-22 21:31

@ Mithu
Posting: # 20715
Views: 1,203
 

 SUPAC level 3 changes for MR formulations

Hi,

» 1. IR product if we change the manufacturing site, do we need to perform BE study as suggested in SUPAC guidance for IR? or it would be okay to justify based on in vitro data?

Did you read the SUPAC guidance for IR?

» 2. For MR product SUPAC MR guidance is not clear for any requirement of conducting BE study. where as we do perform Fasting for such changes in manufacturing site change. are we doing correct?

I dont follow. Are you asking if the study should be a fasted study?

J
Mithu
☆    

India,
2019-10-23 09:21

@ jag009
Posting: # 20716
Views: 1,198
 

 SUPAC level 3 changes for MR formulations

Hi,

» Did you read the SUPAC guidance for IR?

Yes.

» I dont follow. Are you asking if the study should be a fasted study?

Yes. If you see guidance for Food effect, under SUPAC title (for site change), states fasting study is needed and fed generally not needed.

Regards,

Mithu
jag009
★★★

NJ,
2019-10-24 05:34

@ Mithu
Posting: # 20717
Views: 1,150
 

 SUPAC level 3 changes for MR formulations

Hi,

» » Did you read the SUPAC guidance for IR?
» Yes.

Then you should know which level of SUPAC change requires a biostudy. It's in there.

» » I dont follow. Are you asking if the study should be a fasted study?
»
» Yes. If you see guidance for Food effect, under SUPAC title (for site change), states fasting study is needed and fed generally not needed.

Fasting study is the one which SUPAC requires for a site change application.

J
Activity
 Admin contact
20,641 posts in 4,327 threads, 1,437 registered users;
online 28 (1 registered, 27 guests [including 9 identified bots]).
Forum time: 11:44 CEST (Europe/Vienna)

I have had my results for a long time:
but I do not yet know how I am to arrive
at them.    Carl Friedrich Gauß

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