Bioequivalence and Bioavailability Forum

❝ 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 ?

Dear Ohlbe,

Thanks for your reply, the pivotal was done on 36 subjects and done by same CRO, with same Bio parameters as that of pilot study, the release was found to be on higher side as that of Innovators i.e 147 (>125) what are the potential causes and in this even i can not change formulation whether study on more subjects i.e 40 + will solve this issue. Since i am purely from formulation development dont know much about statistical bio designs.

Regards

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]