Bioequivalence and Bioavailability Forum • ANVISA

ANVISA - SABE [Design Issues]

posted by Samaya B – India, 2015-04-27 12:03 (4076 d 23:11 ago) – Posting: # 14741
Views: 9,154

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.

Complete thread:

ANVISA - SABE msmnainar 2015-04-27 09:09
- 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