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jag009
Hero

NJ,
2018-05-24 03:26

Posting: # 18810
Views: 1,019
 

 FDA: Biowaiver on lower strengths [Regulatives / Guidelines]

Hi guys and girls,

Question. When one does the f2 comparisons for a biowaiver on lower strengths, they are usually strength 1 vs RLD strength 2, strength 2 vs RLD strength 2, etc etc. If one passes these comparison but fails f2 for some of the lower strength vs highest strength comparison of the test products themselves, would that be an issue?

Thanks
John
wienui
Regular

Germany, Oman,
2018-05-24 15:25

@ jag009
Posting: # 18813
Views: 853
 

 FDA: Biowaiver on lower strengths

Hi John,

I'm afraid yes. As the lower test strength have to pass the in vitro comparative dissolution testing vs the high bio-batch (which pass the BE study vs the RLD) test strength.
regards,
Osama
Yura
Regular

Belarus,
2018-05-25 10:22

@ jag009
Posting: # 18815
Views: 811
 

 FDA: Biowaiver on lower strengths

Hi John,
The biowaiver for lower dosages (T1, T2) is administered with the dosage (T), which participated in the bioequivalent study.
with respect
Yura
Regular

Belarus,
2018-05-26 17:21

@ Yura
Posting: # 18817
Views: 712
 

 FDA: Biowaiver on lower strengths

Hi John,
...literature, ...justification, ...comparison with the same dose of the originator, ...other statistical approaches.
with respect
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