ANVISA - SABE [Design Issues]
Dear Sundar,
ANVISA accepts SABE design for highly variable drug products.
We have recently submitted a protocol for a HVDP using full repliacted design for ANVISA review. Along with a protocol, you can submit literature references showing >30% ISCV.
Widening criteria for confidence interval remained same as that of EU guidance.
Hope this would be helpful.
Thanks.
Regards,
Samaya.
ANVISA accepts SABE design for highly variable drug products.
We have recently submitted a protocol for a HVDP using full repliacted design for ANVISA review. Along with a protocol, you can submit literature references showing >30% ISCV.
Widening criteria for confidence interval remained same as that of EU guidance.
Hope this would be helpful.
Thanks.
Regards,
Samaya.
Complete thread:
- ANVISA - SABE msmnainar 2015-04-27 09:09 [Design Issues]
- ANVISA - SABE nobody 2015-04-27 09:15
- ANVISA - SABESamaya B 2015-04-27 10:03
- ANVISA - SABE luvblooms 2015-04-27 11:34
- ANVISA - SABE Samaya B 2015-04-27 12:03
- ANVISA - SABE felipeberlinski 2015-04-27 15:36
- ANVISA - SABE msmnainar 2015-04-28 13:11
- ANVISA - SABE felipeberlinski 2015-04-27 15:36
- ANVISA - SABE Samaya B 2015-04-27 12:03
- ANVISA - SABE luvblooms 2015-04-27 11:34