Transitioning Bioanalytical Methods From Pre-Clinical to Clinical Settings: Analytical & Strategic Considerations
Time: 1:30 pm
day: Clinical Stream Day 1 PM
Details:
- Defining and developing Actionable Context of Use (COU) Statements for Bioanalytical Methods
- Analytical Considerations: scalability & Validation differences between a diagnostic vs PK/PD COUs
- Strategic considerations: timing of partial vs full validation
