Points to consider when setting up  in-use stability studies for investigational medicinal products

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In-use stability and compatibility studies are an important aspect of drug development and are required already in early phase clinical studies. The aim of such studies is to investigate the stability of investigational medicinal product (IMP) in a pharmacy/clinical setting and at the same time investigate the compatibility of the drug with the different contact materials used in the preparation and administration of the IMP.

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