ADME Studies
- To compare metabolite profiles from humans and various animal species
- Using liver microsomes, hepatocytes, other subcellular fractions (e.g., liver S9, liver cytosol)
- Available in mouse, rat, dog, monkey and human
- Provide insightful data on specie selection
- To measure the free (unbound) drug concentration in plasma to calculate the plasma protein binding ratio and unbound fraction
- Using plasma and equilibrium dialysis, ultrafiltration or ultracentrifugation
- Available in mouse, rat, dog, monkey and human
- Provide insightful data on drug bioavailability and justification of dose levels in vivo
- Metabolic and Plasma protein data should be evaluated prior to initiating Human clinical trials as per the Guidance for Industry M3(R2)
- Aligns with global regulatory expectations for clinical development