Pre-clinical drug development

During this afternoon we hope to provide a brief introduction to 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

Link: www.trulylabs.com