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001			279681
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008			150903s2009 xxu| o |||| 0|eng d
020			_a9780387856278 _99780387856278
024	7		_a10.1007/9780387856278 _2doi
035			_avtls000333132
039		9	_a201509030213 _bVLOAD _c201404122350 _dVLOAD _c201404092129 _dVLOAD _y201402041103 _zstaff
040			_aMX-SnUAN _bspa _cMX-SnUAN _erda
050		4	_aRM1-950
100	1		_aHuynh-Ba, Kim. _eeditor. _9304152
245	1	0	_aHandbook of Stability Testing in Pharmaceutical Development : _bRegulations, Methodologies, and Best Practices / _cedited by Kim Huynh-Ba.
264		1	_aNew York, NY : _bSpringer New York, _c2009.
300			_axvii, 389 páginas 72 ilustraciones _brecurso en línea.
336			_atexto _btxt _2rdacontent
337			_acomputadora _bc _2rdamedia
338			_arecurso en línea _bcr _2rdacarrier
347			_aarchivo de texto _bPDF _2rda
500			_aSpringer eBooks
505	0		_aStability Regulations -- Critical Regulatory Requirements for a Stability Program -- Understanding ICH Guidelines Applicable to Stability Testing -- Global Stability Practices -- Post-approval Changes – Stability Requirements and Regulations -- Understanding and Predicting Pharmaceutical Product Shelf-Life -- Stability Methodologies and Best Practices -- Development of Stability Indicating Methods -- Method Validation and Transfer -- Overview of USP-NF Requirements for Stability Purposes -- Non-chromatographic Methods to Support Stability Program -- Vibrational Spectroscopic Methods for Quantitative Analysis -- Impact of Solid-State Characteristics to the Physical Stability of Drug Substance and Drug Product -- Evaluation of Stability Data -- Qualification, Calibration, and Maintenance of Stability Chambers -- Stability Operation Practices -- Other Stability Programs -- Combination Products/Drugs in Devices -- Stability Studies for Biologics.
520			_aA COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs. Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners. Topics covered include: Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions. Post-approval considerations and regulatory filing strategies to support a global supply chain. Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications. Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products. Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT). USP-NF testing in support of stability. Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing. Discussion of matrixing and bracketing to support reduced stability testing. Overview of stability programs for biologics and drug-in-devices pharmaceutical products. This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines.
590			_aPara consulta fuera de la UANL se requiere clave de acceso remoto.
710	2		_aSpringerLink (Servicio en línea) _9299170
776	0	8	_iEdición impresa: _z9780387856261
856	4	0	_uhttp://remoto.dgb.uanl.mx/login?url=http://dx.doi.org/10.1007/978-0-387-85627-8 _zConectar a Springer E-Books (Para consulta externa se requiere previa autentificación en Biblioteca Digital UANL)
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