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

Chapter 1 Introduction

Chapter 2 Current Approaches to APSD Measurements of OIPs Based on Inertial Impaction

Chapter 3 Physical Causes of APSD Changes in Aerosols from OIPs and Their Impact on CI Measurements

Chapter 4 Good Cascade Impactor Practices

Chapter 5 The AIM and EDA Concepts: Why They Are Needed and How They Fit Together

Chapter 6 Product Life Cycle Approach to Cascade Impaction Measurements

Chapter 7 Theoretical Basis for the EDA Concept

Chapter 8 Performance Characterization of EDA and Its Potential to Improve Decision Making in Product Batch Release

Chapter 9 Verification of the EDA Concept Through an Assessment of Theoretical Failure Modes, Failure Mode Analysis, and Case Studies with Real Data

Chapter 10 Validating AIM-Based Instrumentation and Associated Measurement Techniques

Chapter 11 The Regulatory and Compendial Pathways to Acceptance for AIM and EDA Concepts

Chapter 12 Applying the AIM Concept in Support of Developing Improved In Vitro–In Vivo Relationships for OIPs

Chapter 14 Conclusions