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Titlebook: Methods for Stability Testing of Pharmaceuticals; Sanjay Bajaj,Saranjit Singh Book 2018 Springer Science+Business Media, LLC, part of Spri

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发表于 2025-3-21 17:01:12 | 显示全部楼层 |阅读模式
书目名称Methods for Stability Testing of Pharmaceuticals
编辑Sanjay Bajaj,Saranjit Singh
视频video
概述Features contributions from labs around to globe to ensure thorough coverage of a wide variety of successful stability programs.Contains key implementation advice from the experts.Provides the kind of
丛书名称Methods in Pharmacology and Toxicology
图书封面Titlebook: Methods for Stability Testing of Pharmaceuticals;  Sanjay Bajaj,Saranjit Singh Book 2018 Springer Science+Business Media, LLC, part of Spri
描述This 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..
出版日期Book 2018
关键词Drug development; Pharmaceutical products; Active Pharmaceutical Ingredient (API); Regulatory guideline
版次1
doihttps://doi.org/10.1007/978-1-4939-7686-7
isbn_softcover978-1-4939-9258-4
isbn_ebook978-1-4939-7686-7Series ISSN 1557-2153 Series E-ISSN 1940-6053
issn_series 1557-2153
copyrightSpringer Science+Business Media, LLC, part of Springer Nature 2018
The information of publication is updating

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发表于 2025-3-21 23:56:29 | 显示全部楼层
Predictive Stability Testing Utilizing Accelerated Stability Assessment Program (ASAP) Studies,dy are described including designing the protocol, setting down the studies, storing and analyzing the samples followed by reviewing and modeling the data and performing predictions. The applications of predictive stability studies are also discussed including in regulatory submissions.
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In Silico Drug Degradation Prediction,substance development. The program uses a knowledge base of chemical transformations together with a reasoning engine to determine the likelihood of a particular degradation product. The knowledge base is continuously expanding and contains a diverse range of chemistries for many common functional groups.
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A Model Approach for Developing Stability-Indicating Analytical Methods,es. Therefore, it makes sense to differentiate the analytical method development and validation strategy between early and late development. In this chapter, we elucidate a strategy to develop liquid chromatography methods that are fit-for-purpose in early development and robust in late development.
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Stability Testing Considerations for Biologicals and Biotechnology Products,ith procedural details. Design considerations of accelerated stability and forced degradation (stress testing) studies for support of manufacturing operations and comparability demonstrations are outlined.
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Protocols for Characterization of Degradation Products with Special Emphasis on Mutagenic Degradati product upon its storage during shelf-life. In this chapter, we describe systematic strategies to proactively select and identify the degradation products that might be considered relevant for safety assessment in accordance with ICH M7.
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