y.asante, post #70: I want to gently push back on the reply above about storage extrapolation. The advice is sound and the confidence is not. We are extrapolating from stability data on a licensed formulation to a preparation that differs in concentration, diluent and container. That extrapolation is reasonable and it is still an extrapolation. Saying so…
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post #123 is right about the mechanism and I think understates the practical bit.
I want to gently push back on the reply above about storage extrapolation. The advice is sound and the confidence is not.
We are extrapolating from stability data on a licensed formulation to a preparation that differs in concentration, diluent and container. That extrapolation is reasonable and it is still an extrapolation. Saying so does not weaken the practical recommendation; it just stops the recommendation from hardening into a fact that someone cites as certain.