(CASE STUDY) Understanding Potency Method Development, Bridging & Life Cycle Strategies
Time: 9:30 am
day: Day 1
Details:
- Presenting a case study of assay development, including MOA-based potency assay design, optimization and robustness studies, and data analysis
- Communicating mechanisms of method qualification and the setting of acceptance criteria
- Extracting learnings from case-study examples of potency method life-cycle management
