PAR not yet [Two-Stage / GS Designs]
Hi All,
We are finding more and more that argumentation via common sense is less and less effective as the years go by. The quality of open mindedness and common sense has gone way down (it's become a potential serious risk to public health!). Giving this trend, we have sorta abondoned science and have gone the way of the sheep in just doing what they ask for. We are getting really frustrated about so many things.
For example, on another project we had several member states demanding a BE study for a certain product at a higher strength, while several others are adamant that it is not ethical to conduct such a study in Europe (some national boards have ruled against it). So, in order to have a chance to place our product on the market we have to go across the great pond to conduct this study, eventhough we consider this unethical. Crazy, common-senseless things going on nowadays.
Thanks to all for the feedback.
We are finding more and more that argumentation via common sense is less and less effective as the years go by. The quality of open mindedness and common sense has gone way down (it's become a potential serious risk to public health!). Giving this trend, we have sorta abondoned science and have gone the way of the sheep in just doing what they ask for. We are getting really frustrated about so many things.
For example, on another project we had several member states demanding a BE study for a certain product at a higher strength, while several others are adamant that it is not ethical to conduct such a study in Europe (some national boards have ruled against it). So, in order to have a chance to place our product on the market we have to go across the great pond to conduct this study, eventhough we consider this unethical. Crazy, common-senseless things going on nowadays.
Thanks to all for the feedback.
Complete thread:
- Two-Stage Sequential Designs Helmut 2010-05-20 16:53
- Two-Stage Sequential Designs yjlee168 2010-05-20 21:28
- Two-Stage Sequential Designs Helmut 2010-05-21 01:06
- EMA: Two-Stage Sequential Designs d_labes 2010-06-15 16:02
- EMA: Two-Stage Sequential Designs Helmut 2010-06-15 16:23
- EMA: Two-Stage Sequential Designs The Outlaw Torn 2011-10-20 10:30
- EMA: Two-Stage Sequential Designs Helmut 2011-10-21 15:01
- PAR? ElMaestro 2011-10-21 15:23
- PAR not yet Helmut 2011-10-21 16:02
- PAR not yet The Outlaw Torn 2011-10-25 08:57
- PAR not yet The Outlaw Torn 2011-10-27 11:07
- Potvin C not acceptable! d_labes 2011-10-27 13:16
- PAR not yet ElMaestro 2011-10-27 13:25
- PAR not yetThe Outlaw Torn 2011-10-31 07:45
- No (?) comment :-( Helmut 2011-10-31 15:04
- PAR not yetThe Outlaw Torn 2011-10-31 07:45
- PAR not yet The Outlaw Torn 2011-10-27 11:07
- PAR not yet The Outlaw Torn 2011-10-25 08:57
- PAR not yet Helmut 2011-10-21 16:02
- PAR? ElMaestro 2011-10-21 15:23
- EMA: Two-Stage Sequential Designs Helmut 2011-10-21 15:01
- EMA: Two-Stage Sequential Designs The Outlaw Torn 2011-10-20 10:30
- EMA: Two-Stage Sequential Designs Helmut 2010-06-15 16:23
- EMA: Two-Stage Sequential Designs d_labes 2010-06-15 16:02
- Two-Stage Sequential Designs Helmut 2010-05-21 01:06
- Two-Stage Sequential Designs yjlee168 2010-05-20 21:28