In numerous scientific fields, high-throughput experimentation methods combined with artificial intelligence (AI) show great ...
Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...
Table 1. Factors to consider in real-time stability study (click to enlarge). Figure 1. Effect of material change on stability profile (click to enlarge). Figure 2. Correleation of stability failure ...
The requirement to formulate biologics in a safe and stable form, and the known propensity for these molecules to aggregate, has led to the need for rigorous stability characterization of these ...
Dynamic Multimode Spectroscopy Found Niche for Monitoring Changes in Secondary Structure In recent years, antibodies and recombinant proteins have become well-established pharmaceutical therapeutics ...
The impact of the lifecycle approach on product development: The implications of implementation of ICH Q7, Q8, Q9, Q10 and Q11 for stability testing Changes to European GMP guidance with impact on ...
Such testing is essential to ensure that the drug product maintains the desired efficacy and purity after transportation and storage. Various constituents of the pharmaceutical product, including the ...
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Read an introduction to this series in Part 1, and Part 2, which covers noise. This is the third and final part in a series which discusses how to properly test a power supply to ensure it will work ...