Tag: medical device

The rapidly accelerating demand for combination products continues to drive technological advances in merging product types. However, the convergence of pharmaceuticals with medical devices brings a host of new challenges in stability studies and storage. At a high level the FDA defines combination products as “therapeutic and diagnostic products that combine drugs, devices, and/or biological … Continued

Development phase Accelerated stability tests provide a means of comparing alternative formula-dons, packaging materials, and/or manufacturing processes in short-term experiments. As soon as the final formulation and manufacturing process have been established, the manufacturer carries out a series of accelerated stability tests which will enable the stability of the drug product or medical device to … Continued