2013

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

ISBN: 978-1-4614-6295-8 (Print) 978-1-4614-6296-5 (Online)

Table of contents (14 chapters)

  1. Front Matter

    Pages i-xii

  2. No Access

    Book Chapter

    Pages 1-13

    Introduction

  3. No Access

    Book Chapter

    Pages 15-55

    Current Approaches to APSD Measurements of OIPs Based on Inertial Impaction

  4. No Access

    Book Chapter

    Pages 57-81

    Physical Causes of APSD Changes in Aerosols from OIPs and Their Impact on CI Measurements

  5. No Access

    Book Chapter

    Pages 83-117

    Good Cascade Impactor Practices

  6. No Access

    Book Chapter

    Pages 119-133

    The AIM and EDA Concepts: Why They Are Needed and How They Fit Together

  7. No Access

    Book Chapter

    Pages 135-149

    Product Life Cycle Approach to Cascade Impaction Measurements

  8. No Access

    Book Chapter

    Pages 151-171

    Theoretical Basis for the EDA Concept

  9. No Access

    Book Chapter

    Pages 173-249

    Performance Characterization of EDA and Its Potential to Improve Decision Making in Product Batch Release

  10. No Access

    Book Chapter

    Pages 251-282

    Verification of the EDA Concept Through an Assessment of Theoretical Failure Modes, Failure Mode Analysis, and Case Studies with Real Data

  11. No Access

    Book Chapter

    Pages 283-357

    Validating AIM-Based Instrumentation and Associated Measurement Techniques

  12. No Access

    Book Chapter

    Pages 359-374

    The Regulatory and Compendial Pathways to Acceptance for AIM and EDA Concepts

  13. No Access

    Book Chapter

    Pages 375-400

    Applying the AIM Concept in Support of Developing Improved In Vitro–In Vivo Relationships for OIPs

  14. No Access

    Book Chapter

    Pages 401-410

    Future Directions for the AIM and EDA Concepts

  15. No Access

    Book Chapter

    Pages 411-417

    Conclusions

  16. Back Matter

    Pages 419-442