Quality by Design for Orally Inhaled Drug Products - PQRI

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Credits• Sau Lee, Ph.D.• Robert Lionberger, Ph.D.• Wallace Adams, Ph.D.• Prasad Peri, Ph.D.• Bing Li, Ph.D.• Dale Conner, Pharm.D.2
What is Pharmaceutical Quality?• Janet Woodcock– Free of contamination and reproducibly delivering thetherapeutic benefit promised in the label to theconsumerPharmaceutical Quality= (Drug substance, excipients,manufacturing, and packaging)• Quality cannot be tested into products; quality canonly be built into products3
Page 1: Quality by Design for Orally Inhale
Page 5 and 6: What Constitutes QbD?Labeled UseSaf
Page 7 and 8: Dry Powder Inhalers• Contain micr
Page 9 and 10: Quality Target Product Profile• A
Page 11 and 12: Quality Target Product Profile for
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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