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The following message was posted to: PharmPK
Is anyone aware of any reason to measure unbound paclitaxcel
concentrations in a phase II trial? It seems that the free fraction
has some complex relationship to the vehicle, but with a single dose
(standard 80 mg/m^2), not clear that it adds anything. Any regulatory
precedent for requesting this in phase II (as opposed to in a renal or
liver failure study)?
Mark Sale MD
Next Level Solutions, LLC
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