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

 
9781461462972: Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products

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Inhaltsangabe

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.

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9781461462958: Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products

Vorgestellte Ausgabe

ISBN 10:  1461462959 ISBN 13:  9781461462958
Verlag: Springer, 2013
Hardcover