Quality Tolerance Limits – Threshold Setting Methodologies
Project Description |
The project has successfully completed an initial phase focused on clarifying definitions and standardising labels associated with QTL monitoring. In addition, recommendations have been established to support the derivation of thresholds for QTL monitoring. The next phase will focus on sharing this knowledge and building a consistent understanding across the wider industry. It will also involve continuing discussions to further refine the statistical methodologies used for threshold derivation. In parallel, the group will closely monitor developments in ICH (R3) guidance on risk-based monitoring and assess any potential implications for the current recommendations, particularly in relation to QTLs and acceptable ranges. |
Project Leads | |
|---|---|
Annett Keller, Boehringer Ingelheim | |
Nathalie van Borrendam, Johnson & Johnson | |
Alex Pearce, PHUSE Project Coordinator |
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