In this thoroughly updated and comprehensive course delegates will be provided with a detailed appraisal
of the rationale and techniques associated with the stability testing of pharmaceuticals and related
products. Aspects covered will include criteria for product stability, challenges associated with specifi c
product types, including biotechnology products, complex formulations and devices, new technology for
stability assessment, and the application and limitations of stability test procedures. UK and international
regulatory aspects will be discussed, including the guidelines for stability testing within the EU, Japan and
the USA introduced through the ICH (International Conference on Harmonisation). Workshop sessions
will use practical examples to illustrate essential steps in the development of stability testing protocols.
Suffi cient time will be available for detailed discussion and questions during the lecture programme.
of the rationale and techniques associated with the stability testing of pharmaceuticals and related
products. Aspects covered will include criteria for product stability, challenges associated with specifi c
product types, including biotechnology products, complex formulations and devices, new technology for
stability assessment, and the application and limitations of stability test procedures. UK and international
regulatory aspects will be discussed, including the guidelines for stability testing within the EU, Japan and
the USA introduced through the ICH (International Conference on Harmonisation). Workshop sessions
will use practical examples to illustrate essential steps in the development of stability testing protocols.
Suffi cient time will be available for detailed discussion and questions during the lecture programme.
