Bioequivalence and Bioavailability Forum

Hi Helmut,

❝ ❝ My question for today: is this still the case/state of science that you can not combine 2-stage and replicate designs?

❝ Yes.

Just predicting: recent update of Moore's law predicts doubling of computer's performance every 2.5 years, so, with current semiconductor technology we may expect that Helmut's new desktop bought in 2028 will be able to do the job within for less than a year (~16 years instead of initial estimate), or we need to create distributed computing technology to parallel calculations on decent number of devices... I've heard that CCTV cameras and home internet routers are running on Linux and almost always use default passwords, and we can use Android phones too ;)

But back to reality: isn't it more practical in case of HVD to perform pilot on development with let's say 50% power (wondering: replicated pilot to keep reasonable small population?), better understand in-vitro in-vivo relationship, optimize formulation and than run replicate scaled trial? In 2-stage we also need to wait for results from the 1st stage...

Regards, VStus