Lab glossary
Control threshold (ICH Q3D)
30% of the PDE of an element in the drug product. If levels are consistently below it, additional controls are generally not needed; above it, controls are put in place.
- Also: 30% of PDE
30% of the PDE of an element in the drug product. If levels are consistently below it, additional controls are generally not needed; above it, controls are put in place.