The Target Concentration Approach to Clinical Drug Development

How is science involved in clinical drug development? From the perspective of many of the readers of Clinical Pharmacokinetics, I am sure that science has a clear contribution to the process by which information is gathered about a drug. However, a broader view provides a fuzzier picture. It is widely held that a substantial fraction of clinical trials submitted to support drug registration provide little or no useful information. It is common for drugs to reach the market with a recommended dose that is often too high. And it costs hundreds of millions of dollars and a decade or more to bring a drug through the discovery and development process. The reasons for this expensive and inefficient and misleading process are complex. I contend that the lack of appropriate application of available science methodologies to the process of drug development is a major factor.