ABSTRACT

Few scientific or business processes carry greater costs and risks than do drug development and manufacture. Pharmaceutical product drug development is a costly endeavor, in terms of both time and money. Over the past three decades, especially in drug development, time has increased to an average of thirteen years, with a cost in excess of $800 million for each new product brought to market. Much of that time and cost are associated with meeting regulatory requirements for nonclinical and clinical research and manufacturing regulations. These are applicable not only in the country of origin but also in those countries targeted as potential markets for the new pharmaceutical products.