Pharmacokinetics and pharmacodynamic biomarkers in early oncology drug development

Abstract

An integrated clinical pharmacology strategy is an essential part of any drug development programme. However, the modern era of oncology therapeutics with its inherent emphasis on molecularly targeted strategies requires a rethinking of our traditional strategies. The growing emphasis on the incorporation of biomarkers into early clinical development programmes is altering the pharmacokinetic (PK) and pharmacodynamic (PD) strategies for the conduct of our early clinical trials. While traditional descriptive PK profiling remains an important endpoint for any first-in-human study, PDs for molecularly targeted therapies have increased in complexity and sophistication.