Bioequivalence and Bioavailability Forum

Pradaxa = HVDP (dabi­ga­tran = HVD?) [Regulatives / Guidelines]

posted by Shuanghe  – Spain, 2015-09-22 18:53 (3931 d 03:35 ago) – Posting: # 15451
Views: 19,713

Hi all,

❝ ❝ BTW: Do you think this sort of BE evaluation is not an "Eintagsfliege" (nine day wonder, ephemera), specific for dabigatran?

❝

❝ No idea. Let’s ask generic companies to follow the path the innovator walked?

There's another guidance of rivaroxaban which takes the same approach as dabigatran.

Unfortunately, I've done BE studies for both dabigatran and rivaroxaban and one of the dossiers have been submitted. Now I have to do some additional analysis according to the new requirements and waiting for the deficient letter to come.

By the way, dabigatran is highly variable under fasting condition but not under fed condition. At least based on my 6 studies (EU/US, pilot/pivotal), all fed study showed ISCV < 30% while all fasting study showed ISCV > 40%.

As for rivaroxaban, it's high variable only for 20mg under fasting. under fed, not so much.

Complete thread:

• New D. Guid­ance – Dabigatran jag009 2015-09-21 23:19 
  • New D. Guid­ance – Dabigatran nobody 2015-09-22 11:04
    • The FDA’s fourth BE approach! Helmut 2015-09-22 11:43
      • The FDA’s fourth BE approach! nobody 2015-09-22 13:06
        • The FDA’s fourth BE approach! Helmut 2015-09-22 13:25
          • The FDA’s fourth BE approach! Yada Yada Yada jag009 2015-09-23 20:29
            • Yucky… Helmut 2015-09-23 22:06
      • The FDA’s fourth BE approach! d_labes 2015-09-22 14:08
        • New PowerTOST function(s) Helmut 2015-09-22 14:27
          • New PowerTOST function(s) d_labes 2015-09-22 14:59
            • Pradaxa = HVDP (dabi­ga­tran = HVD?) Helmut 2015-09-22 15:16
              • Pradaxa = HVDP (dabi­ga­tran = HVD?)Shuanghe 2015-09-22 16:53
                • HVNTID's d_labes 2015-09-23 08:34
                  • HVNTID's Shuanghe 2015-09-25 16:14
              • Highly variable NTID d_labes 2015-09-23 08:23
                • What a mess! Helmut 2015-09-23 13:20
                  • Messy numbers - PowerTOST V1.3-01 preview d_labes 2015-09-24 09:18
                  • What a mess! Shuanghe 2015-09-25 16:32
        • OT: power.NTIDFDA() Helmut 2015-09-23 00:10
          • OT: power.NTIDFDA() d_labes 2015-09-23 09:37