T/R ratio for estimation of sample size in BE study of NTI drugs [Power / Sample Size]
...to be true: I would support discouraging the use of defaults without any knowledge on the actual products (dissolution, pharmaceutical quality etc.). Planning a BE-study should involve that you know that the "correct" GMR / sample size is hindsight knowledge and one way or the other there is a risk to loose money (too many volunteers, too little power to conclude BE), one way ore the other...
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Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- T/R ratio for estimation of sample size in BE study of NTI drugs mahmoud-teaima 2017-10-24 19:18 [Power / Sample Size]
- T/R ratio for estimation of sample size in BE study of NTI drugs Helmut 2017-10-24 23:15
- T/R ratio for estimation of sample size in BE study of NTI drugs ElMaestro 2017-10-25 12:34
- T/R ratio for estimation of sample size in BE study of NTI drugsnobody 2017-10-26 14:03
- Defaults in PowerTOST d_labes 2017-10-26 14:49
- T/R ratio for estimation of sample size in BE study of NTI drugsnobody 2017-10-26 14:03
- T/R ratio for estimation of sample size in BE study of NTI drugs ElMaestro 2017-10-25 12:34
- T/R ratio for estimation of sample size in BE study of NTI drugs Helmut 2017-10-24 23:15