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) determining how to overcome 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