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

Bibliographic Details
Corporate Author: SpringerLink (Online service)
Other Authors: Tougas, Terrence P. (Editor), Mitchell, Jolyon P. (Editor), Lyapustina, Svetlana A. (Editor)
Format: eBook
Language:English
Published: New York, NY : Springer US : Imprint: Springer, 2013.
Edition:1st ed. 2013.
Subjects:
Table of Contents:
  • Introduction
  • Current Approaches To APSD Measurement of OIPs Based on Inertial Impaction
  • Physical Causes of APSD Changes in Aerosols From OIPs and their Impact on Cascade Impactor Measurements
  • Good Cascade Impactor Practices
  • The AIM and EDA Concepts: Why they are Needed
  • Product Lifecycle Approach to Cascade Impaction Measurements
  • Theoretical Basis for the EDA Concept
  • Performance Characterization of EDA and its Potential to Improve Decision Making in Product Batch Release
  • Verification of the EDA Concept through an Assessment of Theoretical Failure Modes, Failure Mode Analysis and Case Studies with Real Data
  • Validating AIM-Based Instrumentation and Associated Measurement Techniques
  • The Regulatory and Compendial Acceptance Pathways for AIM and EDA
  • Applying the AIM Concept in Support of Developing Improved In Vitro-In Vivo Relationships for OIPs
  • Future Directions for the AIM and EDA Concepts
  • Conclusions.