Maitri
☆    

India,
2018-09-21 19:49
(1418 d 21:12 ago)

Posting: # 19297
Views: 2,101
 

 Reference Scale Average Bioequivalence Approach: ANVISA, Brazil [Regulatives / Guidelines]

Hello,

Can any one comment on acceptability of Reference Scale Bioequivalence Approach for ANVISA ( Regulatory agency of Brazil) for highly variable drugs? Do they accept RSABE study design for Highly variable drug compounds?

Thanks & Regards,
Maitri Sanghavi
d_labes
★★★

Berlin, Germany,
2018-09-22 14:11
(1418 d 02:50 ago)

@ Maitri
Posting: # 19298
Views: 1,827
 

 RSABE - ANVISA

Dear Maitri,

» Can any one comment on acceptability of Reference Scale Bioequivalence Approach for ANVISA ( Regulatory agency of Brazil) for highly variable drugs? Do they accept RSABE study design for Highly variable drug compunds?

Have you ever discovered the search field in the upper right corner of the forum?

Use it and you will find some threads dealing with the ANVISA specifications for scaled ABE. E.g. this one.

What do you think: If they have specifications for scaled ABE, do they accept studies using that approach?

Regards,

Detlew
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