The Application of PK/PD Modeling and Simulations During Lead Optimization

A quick view of recent periodicals clearly point to the challenges of the pharmaceutical industry as we progress through the first decade of the 21st century — the rising costs of new innovative drugs. Much of the current costs and the continued rising costs of drug prices stem from the high price of drug discovery and development. Many sources have cited studies that estimate the cost of pharmaceutical drug development; all of which conclude the same — pharmaceutical RD DimAsi et al., 2003). The increase in R&D costs is due mainly to the increased cost of animal testing and conducting clinical trials (Dickson and Gagnon, 2004). The cost of an individual NCE, which is quickly approaching 1 billion dollars, is not the complete source of the large increase in pharmaceutical R&D over the past decade. The development failures of NCEs contribute substantially to this bottom line. One out of every 10 compounds that enter into human testing successfully completes clinical development and is made available to patients. The costs of these failures must be reconciled by the successful marketing of innovative new drugs. The Food and Drug Administration (FDA) recently published a white paper titled “Innovation or Stagnation? - Challenge and Opportunity on the Critical Path to New Medical Products” (FDA, 2004).