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Re: FooBarAndGrill post# 3530

Wednesday, 01/10/2024 9:57:07 AM

Wednesday, January 10, 2024 9:57:07 AM

Post# of 3575
I'm guessing the outcome measures of this clinical trial will provide data needed to supplement the NDA. I don't see this going anywhere beyond that.

Primary Outcome Measures :
AUC of total radioactivity, parent drug and metabolite(s) in plasma.
Cmax of total reactivity, parent drug and metabolite(s) in plasma.
Tmax of total reactivity, parent drug and metabolite(s) in plasma.
Half-life of total reactivity, parent drug and metabolite(s) in plasma.
Elimination rate constant of total reactivity, parent drug and metabolite(s) in plasma.

Secondary Outcome Measures :
Percentage of total radioactivity recovered versus time.
Plasma and whole blood concentration of total radioactivity versus time.
Plasma concentration of parent drug and metabolite(s) versus time.

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