Pivotal and pilot BE Study [Study As­sess­ment]

posted by Ohlbe – France, 2017-07-07 20:29 (2917 d 02:14 ago) – Posting: # 17520
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Dear K Vishal,

❝ My pilot bio study passed which was single dose,single treatment cross -over study with 90% CI 87 - 118% on 16 subjects but pivotal bio study of same fails i.e 82 - 147 %,


How many subjects in your pivotal study ?

It looks like the intra-subject variability is much higher compared with the pilot. Any outlier / subject with "strange" results in the pivotal study ?

Were both studies done by the same CRO ?
—
Regards
Ohlbe

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