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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What Does <strong>Quality</strong> Target ProductProfile Include?• Intended use in clinical setting– Route of administration, dosage <strong>for</strong>m (deliverysystem), and container closure system• <strong>Quality</strong> characteristics of drug product– Appearance, identity, strength, assay, uni<strong>for</strong>mity,purity/impurity, stability, and others• Active pharmaceutical ingredient release ordelivery and attributes affecting pharmacokineticcharacteristics (efficacy & safety)10
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