In vitro ADME
• Screening- Solubility
- Metabolic stability
- Metabolite profiling
- Permeability
- Protein binding
• DDI Profiling
- CYP phenotyping
- CYP inhibition
- CYP induction
- Transporter inhibition
- Transporter involvement
PK Studies
• Rodents/Non-Rodents
- IV/PO
- Single/rising dose levels
- Single/repeat dosing
• Bioananlysis (plasma, tissues)
• PK support for formulation
development
• Efficacy studies
- PK/PD/E correlations
• Human PK prediction
- Allometric scaling
- In vitro-in vivo extrapolation