Bioequivalence and Bioavailability Forum

Hi Maestro,

Heheh, welcome to the crazy strategies of first-to-file generics. Some companies would make multiple formulations based on patents and run them again the marketed product right after it becomes available in hope that one of the tests will be a promising candidate... Yes I have a friend who ran bioanalytical 8 days after the RLD was available in the market.

❝ E.g. your pilot trial on N=12 says the GMR estimate is 92.6 with a CI from 78% to 110%. Would you assume GMR=95% or would you assume 92.6% or something even worse when planning the pivotal?

I would assume GMR of ~90 and power of 85%-90% based on the CV from the pilot, assuming the CV is far away from 30. I would not go below ~90 but then it's up to senior management who pushes my button :P

John