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RegisterLife belt [Two-Stage / GS Designs]
Dear Helmut!
Full ACK.
IMHO we should be glad that we have the option to widen the BE limits at all according to the EMA guidance in case of HVD's. This reduces the burden considerably for such formulations.
Fetching also the advantages of a 2-stage design in this situation would be too much overkill.
Moreover we have to be convinced that our API is HVD. That means that we must have a good reliable estimate of the intra-subject CV (of the reference) which has to be >30%. In that situation an additional life belt for missing or uncertain informations to plan the study aka "2-stage design" is superfluous.
❝ ... But IMHO this is a true show-stopper (aka end of story) unless one has a super-computer in the backyard. Even if we use just 104 sim’s in the sample size estimation that would mean 1010 sim’s for each point of the grid. BTW, even that would only work without intermediate power.
Full ACK.
IMHO we should be glad that we have the option to widen the BE limits at all according to the EMA guidance in case of HVD's. This reduces the burden considerably for such formulations.
Fetching also the advantages of a 2-stage design in this situation would be too much overkill.
Moreover we have to be convinced that our API is HVD. That means that we must have a good reliable estimate of the intra-subject CV (of the reference) which has to be >30%. In that situation an additional life belt for missing or uncertain informations to plan the study aka "2-stage design" is superfluous.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Potvin’s 2-stage adaptive design GSD 2012-08-17 20:56 [Two-Stage / GS Designs]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Potvin’s 2-stage adaptive design + RSABE/ABEL Helmut 2012-08-18 00:39
- Potvin’s 2-stage adaptive design + RSABE/ABEL GSD 2012-08-31 16:30
- Tough job Helmut 2012-08-31 18:37
- Tough job GSD 2012-08-31 19:23
- C/D for EMA? Good luck! Helmut 2012-09-01 15:09
- Surprise? d_labes 2012-09-05 12:57
- Got it. Ages for sims to complete Helmut 2012-09-05 13:35
- Life beltd_labes 2012-09-05 14:51
- Life belt Helmut 2012-09-05 15:20
- Life beltd_labes 2012-09-05 14:51
- Got it. Ages for sims to complete Helmut 2012-09-05 13:35
- Tough job GSD 2012-08-31 19:23
- Tough job Helmut 2012-08-31 18:37
- Power for Two stage Design K2K 2013-10-07 14:43
- Power for Two stage Design Helmut 2013-10-07 14:59
- Power for Two stage Design K2K 2013-10-08 14:35
- “Interim power” Helmut 2013-10-08 14:58
- “Interim power” K2K 2013-10-09 12:39
- Validation of PowerTOST Helmut 2013-10-09 14:10
- Phoenix/WinNonlin - power d_labes 2013-10-09 16:11
- Phoenix/WinNonlin - power Helmut 2013-10-09 18:19
- power K2K 2013-10-10 08:36
- Phoenix/WinNonlin - power Helmut 2013-10-09 18:19
- “Interim power” K2K 2013-10-09 12:39
- “Interim power” Helmut 2013-10-08 14:58
- Power for Two stage Design K2K 2013-10-08 14:35
- Power for Two stage Design Helmut 2013-10-07 14:59
- Potvin’s 2-stage adaptive design + RSABE/ABEL GSD 2012-08-31 16:30
- Potvin’s 2-stage adaptive design + RSABE/ABEL Helmut 2012-08-18 00:39
Ing. Helmut Schütz