CMC Development

Once preclinical feasibility is established and the drug delivery configuration is determined, the next step is to further develop the Chemistry, Manufacturing, and Controls (CMC) aspects required to support filing an IND (FDA) to proceed into a Phase 1 clinical trial. These include the development of the small scale manufacturing process suitable for clinical trial lots and the qualification of the associated test methods, establishment of the specifications, and performing stability studies and lot release tests.


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