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001			978-1-4614-6296-5
003			DE-He213
005			20140220082824.0
007			cr nn 008mamaa
008			130410s2013 xxu| s |||| 0|eng d
020			_a9781461462965 _9978-1-4614-6296-5
024	7		_a10.1007/978-1-4614-6296-5 _2doi
050		4	_aRS380
050		4	_aRS190-210
072		7	_aTDCW _2bicssc
072		7	_aMED072000 _2bisacsh
082	0	4	_a615.19 _223
100	1		_aTougas, Terrence P. _eeditor.
245	1	0	_aGood Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products _h[electronic resource] / _cedited by Terrence P. Tougas, Jolyon P. Mitchell, Svetlana A. Lyapustina.
264		1	_aBoston, MA : _bSpringer US : _bImprint: Springer, _c2013.
300			_aXII, 442 p. 254 illus., 216 illus. in color. _bonline resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_atext file _bPDF _2rda
505	0		_aIntroduction -- 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			_aAerodynamic 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	_aMedicine.
650		0	_aPharmaceutical technology.
650	1	4	_aBiomedicine.
650	2	4	_aPharmaceutical Sciences/Technology.
650	2	4	_aBiomedicine general.
700	1		_aMitchell, Jolyon P. _eeditor.
700	1		_aLyapustina, Svetlana A. _eeditor.
710	2		_aSpringerLink (Online service)
773	0		_tSpringer eBooks
776	0	8	_iPrinted edition: _z9781461462958
856	4	0	_uhttp://dx.doi.org/10.1007/978-1-4614-6296-5
912			_aZDB-2-SBL
999			_c95634 _d95634