Mithu
☆    

India,
2019-09-30 07:42

Posting: # 20651
Views: 509
 

 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: 279
 

 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: 261
 

 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: 221
 

 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
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