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The transition from an IV infusion or SC vial to an SC injection device requires several chemistry, manufacturing and controls (CMC) development activities, as well as clinical and non-clinical, depending on the timing and scope of the change: Formulation development Primary packaging selection and integration with formulation Device selection and device development Drug-device integration Drug product manufacturing process development Bridging studies – Comparative stability studies, including real-time and accelerated stress stability and characterisation – Non-clinical studies – Clinical studies

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By Hurricane Katrina in 2005, I had a science blog and filled it with dispatches about the storm