Case-Study: Bridging Clinical Phase I to III Studies for Small Molecule Development to Demonstrate Quality Consistency & Safety
Time: 9:00 am
day: Conference Day Two
Details:
- Understanding how to use a bridging study to communicate process similarity to health authorities and regulators for streamlined approval
- Outlining the use of modelling to aid bridging studies for similarity demonstrations for maximal efficiency
- Pinpointing data and cost limitations for large biologics and using this as a decisionmaking tool to explain when is best to shift to continuous
