CRED Getting the CMC Dossier Right 2024

05/09/2024

Assessing Changes

• Important not to invalidate any data previously generated

Toxicology Studies

•

Clinical Studies

•

Stability Studies

•

• May not need to completely replace earlier studies but may need smaller or short term ‘bridging’ studies • May be able to use earlier stability data as general support or in a justification for submitting less ‘new data’

• Don’t make big changes late in the development programme

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What Changes could have a serious impact?

• Active Ingredient change in Salt – need bridging tox study

• Active Ingredient, new impurity or increased levels – may need bridging tox study • Active Ingredient, particle size – depending on criticality may need re-validation studies, comparative dissolution for OSD • New API supplier or new commercial manufacturing site – re validation studies

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