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Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products (Record no. 17638)

000 -LEADER
fixed length control field 04846nam a22004335i 4500
003 - CONTROL NUMBER IDENTIFIER
control field OSt
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20140310150238.0
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr nn 008mamaa
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 130410s2013 xxu| s |||| 0|eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781461462965
978-1-4614-6296-5
050 #4 - LIBRARY OF CONGRESS CALL NUMBER
Classification number RS380
Classification number RS190-210
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.19
Edition number 23
264 #1 -
-- Boston, MA :
-- Springer US :
-- Imprint: Springer,
-- 2013.
912 ## -
-- ZDB-2-SBL
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Tougas, Terrence P.
Relator term editor.
245 10 - IMMEDIATE SOURCE OF ACQUISITION NOTE
Title Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products
Medium [electronic resource] /
Statement of responsibility, etc edited by Terrence P. Tougas, Jolyon P. Mitchell, Svetlana A. Lyapustina.
300 ## - PHYSICAL DESCRIPTION
Extent XII, 442 p. 254 illus., 216 illus. in color.
Other physical details online resource.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note 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.
520 ## - SUMMARY, ETC.
Summary, etc Aerodynamic particle size characteristics of orally inhaled products (OIPs) are critical to their performance.  Testing 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.  In recent years, there have been substantial efforts directed at improving aerodynamic particle size determinations.   Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products brings together for the first time a review of best practices for performing cascade impactor testing with a thorough discussion of the recently introduced concepts of abbreviated impactor measurements (AIM) and efficient data analysis (EDA).     Topics covered include:   ·         Review of pharmacopeial methods (US and European) for assessment of aerodynamic particle size distribution (APSD) of OIPs. ·         Physical processes that underlie aerosol formation from OIPs and the mechanisms that affect the APSD. ·         Good cascade impactor practice (GCIP) related to either full resolution or abbreviated impactor measurements.  ·         Introduction of the AIM and EDA concepts. ·         Selection of the type of testing through the development lifecycle of an OIP. ·         Theoretical basis for EDA. ·         Performance evaluation of EDA as a quality control element. ·         Case studies related to the application of  EDA.  ·         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).  ·         Regulatory and compendial pathways to adoption of AIM and EDA. ·         Exploration and extension of AIM as a potential approach to measures that could be more predictive of particle deposition in the human respiratory tract.    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.  IPAC-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.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Medicine.
Topical term or geographic name as entry element Pharmaceutical technology.
Topical term or geographic name as entry element Biomedicine.
Topical term or geographic name as entry element Pharmaceutical Sciences/Technology.
Topical term or geographic name as entry element Biomedicine general.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Mitchell, Jolyon P.
Relator term editor.
Personal name Lyapustina, Svetlana A.
Relator term editor.
710 2# - ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element SpringerLink (Online service)
773 0# - HOST ITEM ENTRY
Title Springer eBooks
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Display text Printed edition:
International Standard Book Number 9781461462958
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier http://dx.doi.org/10.1007/978-1-4614-6296-5
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme
Item type E-Book
Copies
Price effective from Permanent location Date last seen Not for loan Date acquired Source of classification or shelving scheme Koha item type Damaged status Lost status Withdrawn status Current location Full call number
2014-04-05AUM Main Library2014-04-05 2014-04-05 E-Book   AUM Main Library615.19

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