ABSTRACT

Making decisions in the development of drugs is a multifaceted and continuing process. Decisions must be made for scientific and commercial reasons in an ever-changing environment. This chapter aims to discuss scientific aspects of pharmacological and pharmaceutical development which go into decisions bearing on development programmes. As the molecular processes that lead to, or protect from, diseases are becoming understood, an increasing part of pharmacological research is turning towards particular molecules as targets for particular drugs. The chances of success in the biochemical approach to drug development are increased in proportion to the understanding of how a particular molecule or enzymatic reaction acts in a particular disease. Finally, a difficult, but critical, decision in drug development consists of setting priorities within a pharmaceutical company. Clearly, therapeutic need is an important, probably the most important, criterion on which to build priorities. In summary, decision making during a drug development programme is difficult because of uncertainties with respect to the final outcome.