Quality by Design for Orally Inhaled Drug Products - PQRI

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What Does Quality Target ProductProfile Include?• Intended use in clinical setting– Route of administration, dosage form (deliverysystem), and container closure system• Quality characteristics of drug product– Appearance, identity, strength, assay, uniformity,purity/impurity, stability, and others• Active pharmaceutical ingredient release ordelivery and attributes affecting pharmacokineticcharacteristics (efficacy & safety)10
Quality Target Product Profile for DPIs• In vitro performance– Emitted dose– Aerodynamic particle size distribution– Delivered dose uniformity• Product stability and purity• Patient usability/acceptability• Local and systemic delivery– Pharmacokinetic and pharmacodynamicmeasurements11
Page 1 and 2: Quality by Design for Orally Inhale
Page 3 and 4: What is Pharmaceutical Quality?•
Page 5 and 6: What Constitutes QbD?Labeled UseSaf
Page 7 and 8: Dry Powder Inhalers• Contain micr
Page 9: Quality Target Product Profile• A
Page 13 and 14: Formulation Considerations• Physi
Page 15 and 16: Device Considerations• Device mat
Page 17 and 18: Process Development• Understand i
Page 19 and 20: Design Space• Design Space- The m
Page 21 and 22: IPAC-RS (1998-2003)• Nonparametri
Page 23 and 24: 2005 FDA ACPS Meeting Outcome• FD
Page 25 and 26: Control StrategiesLevel 1: Extensiv
Page 27 and 28: Level 2 ControlWDS = Within Design
Page 29 and 30: Control Variability• There is unc

Quality by Design for Orally Inhaled Drug Products - PQRI

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