T/R ratio for estimation of sample size in BE study of NTI drugs [Power / Sample Size]

posted by nobody – 2017-10-26 16:03 (1978 d 02:34 ago) – Posting: # 17921
Views: 6,637

...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... :-)

Kindest regards, nobody

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