Systemic clearance, denoting how much drug is cleared from blood over time, is of critical importance to a drug candidate’s pharmacokinetic (PK) profile. Tools such as the Extended Clearance Classification System (ECCS) and in vitro-in vivo extrapolation (IVIVE) can help predict the rate at which a compound is eliminated and support a risk-based approach to PK evaluation, dosing considerations and clinical study design.
There can be a lot of complexity involved in your drug’s mechanisms and rate of clearance, including turnover by drug-metabolizing enzymes, transport to and from tissues, biliary excretion and more. Fortunately, many of these factors can be estimated using in vitro and in vivo absorption, distribution, metabolism, and excretion (ADME) early in development…