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Highly Variable Drug BE Justification [Regulatives / Guidelines]

posted by ElMaestro - Denmark, 2017-03-20 06:55  - Posting: # 17167
Views: 7,879

Hi jag009,

» What if one conducted pilot studies and found that the ISCV is like 28/29%? My concensus still would be to proceed with RSABE approach since the it is a mixed approach which allows both RSABE(if Ref SD<0.294) and ABE analysis(if Ref SD>0.294)

That's valid, but if you are not really sure if you are just "borderline" then the additional overhead associated with the replicated design may not be worth it. You find an intra-CVR of 31%, and you scale the limits a wee bit etc. But the price you paid for this moderate scaling option could be much higher than you'd be paying for a conventional 222BE trial with a few extra volunteers. Would be interesting to discuss an objective function here :-)

This isn' the answer, but just a view.

“A ten-year, double-blind study from the Mayo Clinic concluded that even in late stages of dementia, the last to go is the lobe of the brain in charge of cafeteria layout.” (Serge Storms/Tim Dorsey).


Best regards,
ElMaestro

- Bootstrapping is a relatively new hobby of mine. I am only 30 years late to the party.

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