000			03629nam a22003735i 4500
001			233837
003			ES-VaUE
005			20221220020524.0
007			cr nn 008mamaa
008			180525s2018 xxu| s |||| 0|eng d
020			_a9781493976867
024	7		_a10.1007/978-1-4939-7686-7 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC
245	1	0	_aMethods for Stability Testing of Pharmaceuticals _cedited by Sanjay Bajaj, Saranjit Singh.
250			_a1st edition 2018
264		1	_aNew York, NY _bSpringer International Publishing _c2018
300			_a1 recurso en línea (XIV, 358 páginas) _b93 ilustraciones, 42 ilustraciones a color
336			_atexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
347			_aarchivo de texto _bPDF
490	0		_aMethods in Pharmacology and Toxicology _x1940-6053
505	0		_aRegulatory Guidelines on Stability Testing and Trending of Requirements -- The Stability Dossier: Common Deficiencies and Ways to Improve -- In Silico Drug Degradation Prediction -- Forced Degradation and Long-Term Stability Testing for Oral Drug Products: A Practical Approach -- A Model Approach for Developing Stability-Indicating Analytical Methods -- Protocols for Characterization of Degradation Products with Special Emphasis on Mutagenic Degradation Impurities -- Stability Studies: Facility and Systems -- User Requirements & Implementation of a Risk-Based, Compliant Stability Management System Based on the FDA New Guidance on DATA Integrity -- Stability Considerations in the Life Cycle of Generic Products -- Predictive Stability Testing Utilizing Accelerated Stability Assessment Program (ASAP) Studies -- Statistical Methods and Approaches to Avoid Stability Failures of Drug Product During Shelf-Life -- Estimation of Stability Based on Monitoring of Shipment and Storage -- Stability Testing Parameters and Issues for Nanotechnology-Based Drug Products -- Stability Testing Issues and Test Parameters for Herbal Medicinal Products -- Stability Testing Considerations for Biologicals and Biotechnology Products.
520			_aThis detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product failures and recalls, requires critical and logical thinking that goes beyond the regular documented protocols and methods, so the experiences of the book's internationally-based expert contributors fill the chapters with practical guidance. As a volume in the Methods in Pharmacology and Toxicology series, this book presents the kind of real-world advice that is essential for advancing laboratory research.  Authoritative and thorough, Methods for Stability Testing of Pharmaceuticals serves as a valuable addition to the existing armamentarium of resources available to stability testing personnel in research and industry.
700	1		_aBajaj, Sanjay _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aSingh, Saranjit _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
776	0	8	_iPrinted edition: _z9781493976850
776	0	8	_iPrinted edition: _z9781493976874
776	0	8	_iPrinted edition: _z9781493992584
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-1-4939-7686-7 _z(usuarios Universidad Europea de Valencia)
942			_2lcc _cLE
988			_aSpringer_Protocols_2018
999			_c233837 _d233837