ABSTRACT
The science of contemporary drug development is a tremendously complex and costly process but it has successfully advanced our understanding of modern diseases and has improved public health significantly by providing society with many valuable drug treatments. A crucial step in the drug development process is the submission of nonclinical and clinical data and information in a New Drug Application (NDA) to the Food and Drug Administration (FDA) by a sponsor seeking marketing authorization. A typical new molecular entity (NME) that is the subject of a NDA has most likely been studied preclinically for 5-7 years and has been in clinical trials for 6-7 years. The average cost of bringing an NME to market is somewhere between 500 and 800 million dollars including the costs of lost opportunities and lead-compound failures [1]. With this investment of time and money, many scientists involved in drug development have explored various ways to make drug development as efficient, and yet informative, as possible [2].
