Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products / edited by Terrence P. Tougas, Jolyon P. Mitchell, Svetlana A. Lyapustina
Contributor(s): Tougas, Terrence P., editor
| Mitchell, Jolyon P, editor literario | Lyapustina, Svetlana A, editor literario
Material type: 
E-bookPublisher: Boston, MA : Springer International Publishing, 2013Description: 1 recurso en línea (XII, 442 p.) 254 il., 216 il. col..ISBN: 9781461462965.Subject: Química farmacéuticaOnline resources: Acceso a este recurso digital (usuarios Universidad Europea de Madrid)
Summary: Aerodynamic particle size characteristics of orally inhaled products (OIPs) are critical to their performance.Â{u0525}sting based on cascade impaction has been the primary tool used to characterize this critical quality attribute and is a regulatory expectation for Quality Control purposes.Â{u026E} recent years, there have been substantial efforts directed at improving aerodynamic particle size determinations. Â{u01EF}od Cascade Impactor Practices, AIM and EDA forÂ{uFCA1}ally Inhaled Products brings together for the first time a review of best practices for performing cascade impactor testing with a thorough discussion of theÂ{u2963}ently introduced concepts of abbreviated impactor measurements (AIM) and efficient data analysis (EDA). Â� Topics covered include: ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Review of pharmacopeial methods (US and European) for assessment of aerodynamic particle size distribution (APSD) ofÂ{uF250}Ps. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Physical processes that underlie aerosol formation from OIPs and the mechanisms that affect the APSD. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Good cascade impactor practice (GCIP) related to either full resolution or abbreviated impactor measurements.·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Introduction of the AIM and EDA concepts. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Selection of the type of testing through the development lifecycle of an OIP. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Theoretical basis for EDA. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Performance evaluation of EDA as a quality control element. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Case studies related to the application ofÂńA.·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Experimental studies validating the AIM concept conducted by European Pharmaceutical Aerosol Group (EPAG) and the Cascade Impaction Working Group of the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS).·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Regulatory and compendial pathways to adoption of AIM and EDA. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Exploration and extension of AIM as a potential approach to measures that could be more predictive of particle deposition in the human respiratory tract.Â� This comprehensive volume was written by a group of prominent international experts in aerosol testing led by members of the Cascade Impaction Working Group of IPAC-RS.Â{u0250}AC-RS is an international association of pharmaceutical companies committed to advancing consensus-based, scientifically driven standards and regulations for orally inhaled and nasal drug products
| Item type | Current library | Collection | Call number | Copy number | Status | Date due | Barcode | Item holds | |
|---|---|---|---|---|---|---|---|---|---|
LIBRO-E NO PRÉSTAMO
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Madrid Digital Acceso Electrónico (UEM) | Ciencias de la Salud | RS403 .G66 2013 EB (Browse shelf(Opens below)) | .i11545057 | Acceso electrónico | eBOOK .i11545057 |
Aerodynamic particle size characteristics of orally inhaled products (OIPs) are critical to their performance.Â{u0525}sting based on cascade impaction has been the primary tool used to characterize this critical quality attribute and is a regulatory expectation for Quality Control purposes.Â{u026E} recent years, there have been substantial efforts directed at improving aerodynamic particle size determinations. Â{u01EF}od Cascade Impactor Practices, AIM and EDA forÂ{uFCA1}ally Inhaled Products brings together for the first time a review of best practices for performing cascade impactor testing with a thorough discussion of theÂ{u2963}ently introduced concepts of abbreviated impactor measurements (AIM) and efficient data analysis (EDA). Â� Topics covered include: ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Review of pharmacopeial methods (US and European) for assessment of aerodynamic particle size distribution (APSD) ofÂ{uF250}Ps. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Physical processes that underlie aerosol formation from OIPs and the mechanisms that affect the APSD. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Good cascade impactor practice (GCIP) related to either full resolution or abbreviated impactor measurements.·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Introduction of the AIM and EDA concepts. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Selection of the type of testing through the development lifecycle of an OIP. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Theoretical basis for EDA. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Performance evaluation of EDA as a quality control element. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Case studies related to the application ofÂńA.·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Experimental studies validating the AIM concept conducted by European Pharmaceutical Aerosol Group (EPAG) and the Cascade Impaction Working Group of the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS).·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Regulatory and compendial pathways to adoption of AIM and EDA. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Exploration and extension of AIM as a potential approach to measures that could be more predictive of particle deposition in the human respiratory tract.Â� This comprehensive volume was written by a group of prominent international experts in aerosol testing led by members of the Cascade Impaction Working Group of IPAC-RS.Â{u0250}AC-RS is an international association of pharmaceutical companies committed to advancing consensus-based, scientifically driven standards and regulations for orally inhaled and nasal drug products
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