Can I read CMC Quality Issues in Clinical Trials on EtoBox?
CMC Quality Issues in Clinical Trials by cokekorea is a document available to read on EtoBox.
What is CMC Quality Issues in Clinical Trials about?
The document discusses quality issues that are considered in the Chemistry, Manufacturing and Controls (CMC) review for clinical trial materials. The CMC review evaluates the identity, strength, purity, and quality of the drug substance and product to ensure subject safety. Impurities, stability, manufacturing controls and specifications are assessed. The level of CMC information required depends on the trial phase, dosage form and duration. Safety concerns include potential toxic impurities and a lack of c
- Author
- cokekorea
- Language
- EN