Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products

1. Introduction
Terrence P. Tougas, Jolyon P. Mitchell, Beth Morgan, Helen Strickland

2. Current Approaches to APSD Measurements of OIPs Based on Inertial Impaction
Jolyon P. Mitchell, Daryl L. Roberts

3. Physical Causes of APSD Changes in Aerosols from OIPs and Their Impact on CI Measurements
Helen Strickland, Beth Morgan, Jolyon P. Mitchell

4. Good Cascade Impactor Practices
Jolyon P. Mitchell

5. The AIM and EDA Concepts: Why They Are Needed and How They Fit Together
Jolyon P. Mitchell, Terrence P. Tougas

6. Product Life Cycle Approach to Cascade Impaction Measurements
Richard Bauer, J. David Christopher, Volker Glaab, Svetlana A. Lyapustina, Jolyon P. Mitchell, Terrence P. Tougas

7. Theoretical Basis for the EDA Concept
Terrence P. Tougas, Jolyon P. Mitchell

8. Performance Characterization of EDA and Its Potential to Improve Decision Making in Product Batch Release
J. David Christopher, Helen Strickland, Beth Morgan, Monisha Dey, Alan Silcock, Terrence P. Tougas, Jolyon P. Mitchell, Svetlana A. Lyapustina

9. Verification of the EDA Concept Through an Assessment of Theoretical Failure Modes, Failure Mode Analysis, and Case Studies with Real Data
Helen Strickland, Beth Morgan, J. David Christopher, Volker Glaab, Adrian Goodey, Keyur Joshi, Lei Mao, Jolyon P. Mitchell

10. Validating AIM-Based Instrumentation and Associated Measurement Techniques
Mark Copley, Jolyon P. Mitchell, Mårten Svensson, J. David Christopher, Jorge Quiroz, Geoffrey Daniels, Melanie Hamilton, Dave Russell-Graham

11. The Regulatory and Compendial Pathways to Acceptance for AIM and EDA Concepts
Steven C. Nichols, Jolyon P. Mitchell, Terrence P. Tougas, J. David Christopher, Susan Holmes

12. Applying the AIM Concept in Support of Developing Improved In Vitro–In Vivo Relationships for OIPs
Jolyon P. Mitchell, Mark Copley, Derek Solomon

13. Future Directions for the AIM and EDA Concepts
Terrence P. Tougas, Jolyon P. Mitchell

14. Conclusions
Terrence P. Tougas, Svetlana A. Lyapustina, Jolyon P. Mitchell

Nyckelord: Biomedicine, Pharmaceutical Sciences/Technology, Biomedicine general