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020 _a9781493976867
_9978-1-4939-7686-7
024 7 _a10.1007/978-1-4939-7686-7
_2doi
050 4 _aRM300-666
072 7 _aMMG
_2bicssc
072 7 _aMED071000
_2bisacsh
072 7 _aMKG
_2thema
082 0 4 _a615
_223
245 1 0 _aMethods for Stability Testing of Pharmaceuticals
_h[electronic resource] /
_cedited by Sanjay Bajaj, Saranjit Singh.
250 _a1st ed. 2018.
264 1 _aNew York, NY :
_bSpringer New York :
_bImprint: Humana,
_c2018.
300 _aXIV, 358 p. 93 illus., 42 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
490 1 _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.
650 0 _aPharmacology.
650 1 4 _aPharmacology.
700 1 _aBajaj, Sanjay.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
700 1 _aSingh, Saranjit.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
710 2 _aSpringerLink (Online service)
773 0 _tSpringer Nature eBook
776 0 8 _iPrinted edition:
_z9781493976850
776 0 8 _iPrinted edition:
_z9781493976874
776 0 8 _iPrinted edition:
_z9781493992584
830 0 _aMethods in Pharmacology and Toxicology,
_x1940-6053
856 4 0 _uhttps://doi.org/10.1007/978-1-4939-7686-7
912 _aZDB-2-PRO
999 _c5993
_d5993