ABSTRACT
Drug development has undergone dramatic changes in recent years. A few decades ago, it was an empirical field inadequately organized and often pushed by pharmacologists or clinicians to develop new drug products. Decision making was erratic, and development time was long. The number of failed trials was high, and many projects did not result in marketable products for therapeutic use. Today, under the influence of scientific progress, increased regulatory activities, and economic factors, the drug development process has become more complicated and rational. It is now necessary for the pharmaceutical industry to maximize returns on the huge investments that are now required to develop new drugs. Also, the quality of products and speed of manufacturing must be improved. Decision making in the various stages of preclinical research and clinical trials plays an important role.
