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What is CMC Requirements for Biological IMPD about?

This document provides an overview of a presentation on preparing the CMC section of an IMPD for biological/biotechnology derived substances. It discusses the evolution of quality requirements, key documents to consult, and information that needs to be provided, such as characterization, manufacturing process development and comparability, specifications, and stability and shelf-life claims. The presentation also discusses strategies to identify and mitigate risks for first-in-human clinical trials with IMP

Author

gasiasi

Language

EN