Knowing When To Lock Down A Biologics TPP
Source: Drug Delivery Leader
In this segment of the Drug Delivery Leader Live online event, Large Molecule Biologics Delivery: Aligning Formulations, Doses, And Devices, Chief Editor Tom von Gunden directs to panelist Rubi Burlage an audience question about timetable for finalizing a TPP (Target Product Profile) during product development. While acknowledging the iterative nature of a TPP, Burlage recommends Phase III as the ideal stage for a lockdown and advises against late changes at validation.
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