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02949nam a22002775i 4500 |
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20210601114840.0 |
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cr nn 008mamaa |
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100301s2010 xxu| s |||| 0|eng d |
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|a 9781441908896
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| 024 |
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|a 10.1007/978-1-4419-0889-6
|2 doi
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| 040 |
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|a Sistema de Bibliotecas del Tecnológico de Costa Rica
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| 245 |
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|a Pharmaceutical Stability Testing to Support Global Markets /
|c edited by Kim Huynh-Ba.
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| 250 |
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|a 1st ed. 2010.
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| 260 |
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|a New York, NY :
|b Springer New York :
|b Imprint: Springer,
|c 2010.
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| 300 |
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|a XX, 266 p. 11 illus., 4 illus. in color. :
|b online resource.
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| 336 |
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|a text
|b txt
|2 rdacontent
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|a computer
|b c
|2 rdamedia
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| 338 |
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|a online resource
|b cr
|2 rdacarrier
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| 490 |
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|a Biotechnology: Pharmaceutical Aspects ;
|v XII
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|a Section I -- Stability Studies in a Global Environment -- Regulatory Perspectives on Product Stability -- Current International Harmonization Efforts -- Update on the WHO Stability Guideline -- Development of a Regional Guideline for the Eastern Mediterranean Region -- The Challenge of Diverse Climates: Adequate Stability Testing Conditions for India -- Requirements for South East Asian Markets -- The Role of USP Monographs in Stability Testing -- Regulatory Requirements for Stability Testing of Generics -- Stability Design for Consumer Healthcare Products -- Challenges of Drug/Devices Pharmaceutical Products -- Practical Challenges of Stability Testing of Nutraceutical Formulations -- Setting Tolerances for Instrument Qualification USP Chapter -- Technical Concepts for Stability Program -- The Concept of Quality-by-Design -- Forced Degradation and Its Relation to Real Time Drug Product Stability -- Low Level Impurities in Drug Substances and Drug Products and the Analytical Challenges in Identification and Quantitation -- Stability of Repackaged Products -- Packaging-Induced Interactions and Degradation -- An Overview of Physical Stability of Pharmaceuticals -- Stability of Split Tablets -- Temperature Monitoring During Shipment and Storage -- Introducing a Science-Based Quality by Design Concept to Analytical Methods Development -- Stability Data and Operational Practices -- Optimizing Stability Data Package to Facilitate NDA/MAA Approval -- Maximize Data for Post Approval Changes -- Use of Statistics to Establish a Stability Trend: Matrixing -- Setting Specifications for Drug Substances -- Setting Specifications for Drug Products -- Highlights of Investigating Out-of-Specifications Test Results -- Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced Stability Programs -- Building and Developing of Relationships with Third Party Laboratories -- Outsourcing Stability Testing: A Tool for Resource and Risk Management.
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| 650 |
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|a Pharmacology.
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| 650 |
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4 |
|a Pharmacology/Toxicology.
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| 700 |
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|a Huynh-Ba, Kim.
|e editor.
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| 710 |
2 |
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|a SpringerLink (Online service)
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| 773 |
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|t Springer eBooks
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