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RegisterTSD only an option in exceptional cases [Two-Stage / GS Designs]
Dear all,
Thank you very much for the effort you spent to teach me where the pitfalls of a TSD study lie. Fortunately in vain (not the teaching but I just heard that the project is cancelled. I guess performing a study with a supposed CVintra of 50% for AUC and 80% for Cmax is only interesting from a scientific point of view). As you know I am not a friend of TSD and this discussion confirmed my antipathy. IMHO as long as you have a "normal" drug substance you should go with an accepted design. I would use a full replicate design with the possibility to widen the acceptance range (at least for Cmax). The savings in terms of money of a TSD (if any!) do no justify the risks.
Kind regards and thanks again
Dr_Dan
Thank you very much for the effort you spent to teach me where the pitfalls of a TSD study lie. Fortunately in vain (not the teaching but I just heard that the project is cancelled. I guess performing a study with a supposed CVintra of 50% for AUC and 80% for Cmax is only interesting from a scientific point of view). As you know I am not a friend of TSD and this discussion confirmed my antipathy. IMHO as long as you have a "normal" drug substance you should go with an accepted design. I would use a full replicate design with the possibility to widen the acceptance range (at least for Cmax). The savings in terms of money of a TSD (if any!) do no justify the risks.
Kind regards and thanks again
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Does unequal alpha distribution make sense? Dr_Dan 2015-05-19 08:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Maybe; but watch the TIE! Helmut 2015-05-28 15:04
- Advantages d_labes 2015-06-05 09:35
- Advantages ElMaestro 2015-06-05 10:07
- Advantages – performance measure d_labes 2015-06-05 11:21
- Advantages – performance measure Helmut 2015-06-05 13:29
- Advantages – performance measure d_labes 2015-06-05 21:27
- Advantages – performance measure Helmut 2015-06-05 23:29
- Histogram wonder d_labes 2015-06-06 12:58
- Histogram charlatanry Helmut 2015-06-09 13:43
- Histogram beauty d_labes 2015-06-09 14:55
- Histogram beast Helmut 2015-06-09 15:24
- Histogram beauty d_labes 2015-06-09 14:55
- Histogram charlatanry Helmut 2015-06-09 13:43
- Histogram wonder d_labes 2015-06-06 12:58
- Advantages – performance measure Helmut 2015-06-05 23:29
- Advantages – performance measure d_labes 2015-06-05 21:27
- Advantages – performance measure Helmut 2015-06-05 13:29
- Advantages – performance measure d_labes 2015-06-05 11:21
- Advantages ElMaestro 2015-06-05 10:07
- Advantages d_labes 2015-06-05 09:35
- Does unequal alpha distribution make sense? Dr_Dan 2015-05-29 08:33
- Does unequal alpha distribution make sense? ElMaestro 2015-05-29 09:31
- Does unequal alpha distribution make sense? nobody 2015-05-29 12:56
- Old beliefs die hard Helmut 2015-05-29 13:27
- Old beliefs die hard nobody 2015-05-29 13:41
- Old beliefs die hard Helmut 2015-05-29 18:08
- Old beliefs die hard ElMaestro 2015-05-29 18:57
- Old beliefs die hard nobody 2015-05-29 20:06
- ♩ ♪♫♬`·.¸¸.·´`·.¸¸. Helmut 2015-06-02 01:52
- TSD only an option in exceptional casesDr_Dan 2015-06-02 08:00
- TSD only an option in exceptional cases nobody 2015-06-02 09:23
- TSD only an option in exceptional casesDr_Dan 2015-06-02 08:00
- Old beliefs die hard ElMaestro 2015-05-29 18:57
- Old beliefs die hard Helmut 2015-05-29 18:08
- Old beliefs die hard nobody 2015-05-29 13:41
- Old beliefs die hard Helmut 2015-05-29 13:27
- Does unequal alpha distribution make sense? nobody 2015-05-29 12:56
- Does unequal alpha distribution make sense? ElMaestro 2015-05-29 09:31
- Banana splits Helmut 2015-06-02 00:48
- Maybe; but watch the TIE! Helmut 2015-05-28 15:04
Ing. Helmut Schütz