Bioequivalence and Bioavailability Forum

Hi Mahesh and Kumar,

❝ ❝ Is it required to mention Pilot or Pivotal study in protocol (protocol Title) ?

❝

❝ I think in pivotal studies we don't need to specify…

Agree.

❝ … but in pilot studies we generally write in sample size section that this much sample size (generally 12) will be considered for the pilot study.

We once had a case, where the Austrian authority – although “pilot study” was stated in the title – after submitting the protocol asked why we designed the study for such a small sample size. Obviously they did not read the title and neither comprehend the study’s objective nor the sample size section. BTW, why “generally 12”? What’s so particular about a dozen?