Highly variable NTID [Regulatives / Guidelines]
Dear Helmut,
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 really dirty story
. So much to "To cheat is Indian" (My exculpation to the Indian members of this forum).
❝ ❝ 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

—
Regards,
Detlew
Regards,
Detlew
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! Yada Yada Yada jag009 2015-09-23 20:29
- The FDA’s fourth BE approach! Helmut 2015-09-22 13:25
- 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
- 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
- What a mess! Helmut 2015-09-23 13:20
- Pradaxa = HVDP (dabigatran = HVD?) Helmut 2015-09-22 15:16
- New PowerTOST function(s) d_labes 2015-09-22 14:59
- OT: power.NTIDFDA() Helmut 2015-09-23 00:10
- OT: power.NTIDFDA() d_labes 2015-09-23 09:37
- New PowerTOST function(s) Helmut 2015-09-22 14:27
- The FDA’s fourth BE approach! nobody 2015-09-22 13:06
- The FDA’s fourth BE approach! Helmut 2015-09-22 11:43
- New D. Guidance – Dabigatran nobody 2015-09-22 11:04