jag009
★★★

NJ,
2018-05-24 05:26
(2163 d 15:35 ago)

Posting: # 18810
Views: 2,751
 

 FDA: Biowaiver on lower strengths [Regulatives / Guidelines]

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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
★    

Germany/Oman,
2018-05-24 17:25
(2163 d 03:36 ago)

@ jag009
Posting: # 18813
Views: 2,271
 

 FDA: Biowaiver on lower strengths

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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
—
Cheers,
Osama
 
Yura
★    

Belarus,
2018-05-25 12:22
(2162 d 08:40 ago)

@ jag009
Posting: # 18815
Views: 2,195
 

 FDA: Biowaiver on lower strengths

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

Belarus,
2018-05-26 19:21
(2161 d 01:41 ago)

@ Yura
Posting: # 18817
Views: 2,093
 

 FDA: Biowaiver on lower strengths

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