Pre-clinical drug development
Topics include:
- Deciding the destination – Target Product Profile
- Assembling a toolbox – Screening assays and biological models
- Understanding how much and when to dose – Quantitative Pharmacology (PK/PD)
- Translating to the clinic – Biomarker tools
- Building the regulatory package – Documentation
Key take-aways:
- Important strategic decisions
- Practical tools required in the lab
- Documentation & regulatory package
Presentation by SmiLe Alumni members Charlott Brunmark and Karin von Wachenfeldt from Truly Labs