Bioequivalence and Bioavailability Forum

Highly variable NTID [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2015-09-23 10:23 (3464 d 15:24 ago) – Posting: # 15454
Views: 17,310

Dear Helmut,

❝ ❝ I had interpreted the sentence "Dabigatran demonstrated a steep exposure response relationship for both efficacy and safety." as some sort of NTID.

❝

❝ Me too. Seems that the innovator (Boehringer Ingelheim) assessed the variabilities in its studies.

❝ This is the first example I’m aware of were the observation “HVDs/HVDPs are safe drugs since they have a flat dose/response-curve” seemingly does not hold.

Oh I see. That's the reason for the sentence "Therefore applicants should not use the reference-scaled average bioequivalence (BE) approach to widen the BE limits for dabigatran BE evaluation" in the dabigatran guidance.

Seems it's time for a new term: HVNTID

❝ A dirty story? Wikipedia ...

A really dirty story . So much to "To cheat is Indian" (My exculpation to the Indian members of this forum).

Complete thread:

• New D. Guid­ance – Dabigatran jag009 2015-09-21 23:19 [Regulatives / Guidelines] 
  • 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 NTIDd_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