The FDA’s fourth BE approach! [Regulatives / Guidelines]
Hi nobody,
As if pulling a rabbit out of the hat. László Endrényi regularly goes ballistic on this issue. He showed already twenty years ago (in the context of IBE) that this limit is arbitrary and the “method” flawed.
❝ Please elucidate the scientific background for the "upper limit of the 90% confidence interval for the test-to-reference ratio of the within-subject variability should be ≤ 2.5" of FDA dabigatran BE guidance
As if pulling a rabbit out of the hat. László Endrényi regularly goes ballistic on this issue. He showed already twenty years ago (in the context of IBE) that this limit is arbitrary and the “method” flawed.
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Helmut Schütz
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Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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