Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products /
| Autor Corporativo: | |
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| Otros Autores: | , , |
| Formato: | eBook |
| Lenguaje: | English |
| Publicado: |
New York, NY :
Springer US : Imprint: Springer,
2013.
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| Edición: | 1st ed. 2013. |
| Materias: |
Tabla de Contenidos:
- 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.