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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Freeze

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.

Detoxification

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.

synchronous

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.

糾纏

LIEN

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.

Infiltrate

figment

BRIDE

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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