ABSTRACT
For more than a decade now, pharmaceutical R & D expenditures in the United States have grown steadily at a rate of about 15% per year [1]. Over the same period the number of new drugs approved by the FDA has remained at ap proximately 23 per year [2]. Consequently, the investment in bringing a new chemical entity (NCE) to the pharmacist’s shelf has risen steadily. Recent analysis now puts the development cost at $231 million [3], and there is every reason to believe the cost of drug development will continue to rise.
