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The following message was posted to: PharmPK Let us assume an
intravenous product approved in the US and abroad. The company seeks
to modify the dosing from that indicated on the approved label to a
simpler approach. Good PK models exist, but the correlation between
drug concentration and effect is not strong. Does it seem likely
that this innovator could argue for this labeling change with
simplified dosing without a confirmatory clinical study if the PK
models showed that the pharmacokinetic parameters such as Cmax and
AUC fell within the 85-120% expected of a biopharmaceutically
In other words, do you think the innovator could argue for the
labeling change on the basis that it yields a predicted PK profile
similar to what an acceptable generic would be permitted to have?
Thanks in advance.
Paul R. Hutson, Pharm.D.
UW School of Pharmacy
777 Highland Avenue
Madison WI 53705-2222
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