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CMC Considerations in Investigator Brochure: Essential Guidelines for Clinical Development

This presentation provides an overview of the critical Chemistry, Manufacturing, and Controls (CMC) considerations outlined in the Investigator Brochure. It delves into the CMC requirements, parallels between product and clinical development, available guidance documents, and essential information on CMC IND requirements. The format and content requirements according to 21 CFR 312 and 21 CFR 211 are also discussed, including details on expiry dates.

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CMC Considerations in Investigator Brochure: Essential Guidelines for Clinical Development

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