To pool or not to pool [Software]
Hi Zan,
Sure. The text contains a reference:
Please no more TOFU in future posts. THX.
❝ Was it due to significant effect observed for Group x Treatment that resulted in the reviewer's decision to run final analysis by separate groups (on Page 5)?
Sure. The text contains a reference:
In control #98-392 (see attachment), it is stated that “if the Group-by-Treatment interaction is statistically significant (p<0.1), DBE requested that equivalence be demonstrated in one of the groups, provided that the group meets minimum requirements for a complete bioequivalence study”.
However, #98-392 is not attached. I failed to dig it out at the FDA (controlled correspondence not covered by FOI?). Note the wording almost identical to my post above.Please no more TOFU in future posts. THX.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Phoenix WNL to handle 2x2 crossover study with multip group zan 2014-06-27 23:29
- Phoenix WNL to handle 2x2 crossover study with multip group ElMaestro 2014-06-28 23:23
- Group effect commonly not relevant Helmut 2014-06-30 16:55
- Group effect in 2x2 BE study zan 2014-06-30 19:18
- Group effect in 2x2 BE study ElMaestro 2014-06-30 20:36
- To pool or not to pool Helmut 2014-06-30 20:51
- To pool or not to pool zan 2014-06-30 21:02
- To pool or not to pool Helmut 2014-06-30 21:38
- To pool or not to pool zan 2014-06-30 21:46
- To pool or not to poolHelmut 2014-06-30 22:22
- To pool or not to pool zan 2014-07-01 01:15
- Partial vs. sequential tests in WNL Helmut 2014-07-01 12:26
- Partial vs. sequential tests in WNL zan 2014-07-01 18:03
- Loosing patience Helmut 2014-07-01 18:23
- Partial vs. sequential tests in WNL zan 2014-07-01 18:03
- Partial vs. sequential tests in WNL Helmut 2014-07-01 12:26
- To pool or not to pool zan 2014-07-01 01:15
- To pool or not to poolHelmut 2014-06-30 22:22
- To pool or not to pool ElMaestro 2014-06-30 22:11
- To pool or not to pool zan 2014-07-01 01:18
- To pool or not to pool zan 2014-07-02 19:56
- To pool or not to pool ElMaestro 2014-07-03 00:17
- To pool or not to pool zan 2014-07-03 00:36
- sequence- / period effect #666 Helmut 2014-07-03 10:05
- To pool or not to pool ElMaestro 2014-07-03 00:17
- To pool or not to pool zan 2014-06-30 21:46
- To pool or not to pool Helmut 2014-06-30 21:38
- To pool or not to pool zan 2014-06-30 21:02
- Group effect commonly not relevant AngusMcLean 2014-07-06 16:19
- Group effect commonly not relevant Helmut 2014-07-06 20:32
- Group effect commonly not relevant AngusMcLean 2014-07-06 22:52
- Group effect commonly not relevant Helmut 2014-07-06 23:57
- PHX: Parameter mapping AngusMcLean 2014-07-07 15:04
- PHX: Parameter mapping Helmut 2014-07-07 15:45
- PHX: Parameter mapping Shuanghe 2014-07-07 17:35
- Great hint! Helmut 2014-07-07 17:54
- PHX: Parameter mapping AngusMcLean 2014-07-07 20:49
- PHX: Parameter mapping AngusMcLean 2014-07-07 18:46
- PHX: Parameter mapping Shuanghe 2014-07-07 17:35
- PHX: Parameter mapping Helmut 2014-07-07 15:45
- PHX: Parameter mapping AngusMcLean 2014-07-07 15:04
- Group effect commonly not relevant Helmut 2014-07-06 23:57
- Group effect commonly not relevant AngusMcLean 2014-07-06 22:52
- Group effect commonly not relevant Helmut 2014-07-06 20:32
- Group effect in 2x2 BE study zan 2014-06-30 19:18