Information-rich Phase I

An existing Phase I study can be enhanced substantially and very cost-effectively to obtain human metabolite profile, clearance, volume of distribution and absolute bioavailability data. 

These studies can yield the following immediate benefits:

• FDA/MIST Human metabolism profile to compare with preclinical metabolite profile and relative concentrations
• IVPK Insight to formulation challenge, late stage clinical outcomes and regulatory expectations (particularly in Europe)