Maitri
☆    

India,
2018-09-21 21:49
(2015 d 15:35 ago)

Posting: # 19297
Views: 2,358
 

 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 16:11
(2014 d 21:13 ago)

@ Maitri
Posting: # 19298
Views: 2,039
 

 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
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
107 visitors (0 registered, 107 guests [including 9 identified bots]).
Forum time: 12:24 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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