Hello fellow Stabilitarians!
As a general question regarding cell therapies, if there is a target dosage for the cell density and volume (i.e. product spec = 1.0 x10^6 cells/mL) how tight does our dose need to be to the spec? Is a +/- of 20%, 30% or 50% relative to the spec considered acceptable by regulators? Would I need to initiate 3 separate studies for mid, high and low dosage forms based on the target dose and each dose from the +/-?
Where is that line drawn in such a new area in the pharma industry?