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I have heard that the FDA has approved labeling for a drug dose based on
simulations, even though that particular dose had not been tested in a
clinical trial. I would very much appreciate some details on this if
of you are familiar with the situation.
I think you might be referring to the NSAID from Syntex, Ketorolac. "AsBack to the Top
I recall, the approved dose was between two studied doses, not sure
what role simulation played. "Rather it was more like interpolation.
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