FDA's Keith Webber on Setting Specifications - Find Pharma
FDA's Keith Webber on Setting Specifications

Source: BioPharm International


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FDA´s Keith Webber on Setting Specifications



Keith Webber, PhD, Deputy Director of the Office of Pharmaceutical Science, CDER, FDA discusses how product specifications for biological products apply to individual samples or averages; the use of specifications vs. control limits; stability results, and more.

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Source: BioPharm International,
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