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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Why is QbD More Significant to<strong>Orally</strong> <strong>Inhaled</strong> <strong>Drug</strong> <strong>Products</strong>?• Inhalation manufacturing often exhibits lowprocess capability• Product is a device in association with a<strong>for</strong>mulation• Product handling may affect received dose• Environmental effects may influence productmanufacture and use• Low testing efficiency of aerodynamic particleassessment methods• Lack of clear in vitro - in vivo correlationsN. Bowles et al. <strong>Drug</strong> Delivery to the Lungs 18, The Aerosol Society, Edinburgh, UK, 2007:75-78 8
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