Quality by Design for Orally Inhaled Drug Products - PQRI
Quality by Design for Orally Inhaled Drug Products - PQRI
Quality by Design for Orally Inhaled Drug Products - PQRI
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Conclusion• <strong>Quality</strong> <strong>by</strong> <strong>Design</strong>– is the basis <strong>for</strong> science-based regulatorydecisions– sponsors need to share PharmaceuticalDevelopment in<strong>for</strong>mation in the application• Generic Inhalation <strong>Products</strong>– Many opportunities to use QbD to developequivalent drug products30