New PowerTOST function(s) [Regulatives / Guidelines]
Dear Helmut,
Thanks! It was very recreative. And I could practise what I have to do if I will be a rendeer (German Rentier) next time.
Doing nothing the whole blessed day but "Maulaffen feil halten" (to gawk, to sit on one's hands)
.
That astonishes me. I had interpreted the sentence "Dabigatran demonstrated a steep exposure response relationship for both efficacy and safety." as some sort of NTID.
Good idea. I will wait for his reaction.
BTW: Do you think this sort of BE evaluation is not an "Eintagsfliege" (nine day wonder, ephemera), specific for dabigatran?
❝ welcome back! How was vacation on the lonesome isle far out on the high seas?
Thanks! It was very recreative. And I could practise what I have to do if I will be a rendeer (German Rentier) next time.
Doing nothing the whole blessed day but "Maulaffen feil halten" (to gawk, to sit on one's hands)

❝ I would not add other argument(s) to power.NTIDFDA()
. AFAIK dabigatran is not a NTID.
That astonishes me. I had interpreted the sentence "Dabigatran demonstrated a steep exposure response relationship for both efficacy and safety." as some sort of NTID.
❝ Let’s ask Ben as well.
Good idea. I will wait for his reaction.
BTW: Do you think this sort of BE evaluation is not an "Eintagsfliege" (nine day wonder, ephemera), specific for dabigatran?
—
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 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
- 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