Critical Parameters in Targeted Drug Development: The Pharmacological Audit Trail

The pharmacological audit trail (PhAT) comprises a set of critical questions that need to be asked during discovery and development of an anticancer drug. Key aspects include: 1) defining a patient population; 2) establishing pharmacokinetic characteristics; 3) providing evidence of target engagement, pathway modulation, and biological effect with proof of concept pharmacodynamic biomarkers; 4) determining intermediate biomarkers of response; 5) assessing tumor response; and 6) overcoming resistance by combination or sequential therapy and new target/drug discovery.

Source: Seminars in Oncology - June 12, 2016 Category: Cancer & Oncology Authors: Udai Banerji, Paul Workman Source Type: research