Stability studies are used to assess the shelf life of a product by storing samples under differing conditions, typically as defined by regulatory authorities, and then testing samples taken from ...

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 ...

Dynamic light scattering presents a good analytical technique for testing protein stability. Dynamic light scattering (DLS) is a well-known technique for determining sample interactions, particle size ...

The importance of capability and capacity of a CDMO partner to deliver drug substance and product testing should never be underestimated, considering the increasing complexity of compounds in ...

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 ...

A series of practical exercises will take place throughout the programme to give participants the opportunity to apply their knowledge under the guidance of our experienced trainers.

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 ...

Biologics stability testing in pharmaceutical R&D typically requires weeks of waiting between processes. Formulation scientists must develop, assess, and then wait to discover if a formulation remains ...

While stability testing for small molecule drugs is well established, its counterpart for biologicals is still evolving. Dozens of techniques have emerged for characterizing proteins, ranging from the ...

The purpose of this course is to give a comprehensive, integrated overview of pharmaceutical stability testing. It will include, A comprehensive review of ICH guidance, Pitfalls in stability testing, ...