The Role of Pharmacometrics in Cardiovascular Drug Development

Minto and Schnider (1 ) have pointed out that “Rapidly evolving changes in health care economics and consumer expectation make it unlikely that traditional drug development approaches will succeed in the future. A shift away from the narrow focus on rejecting the null hypothesis toward a broader focus on seeking to understand the factors that influence the dose—response relationship together with the development of the next generation of software based on population models (see Section 2.5. for the definition of population models) should permit a more efficient and rational drug development programme.” Their comments are further supported by the fact that the direct cost of drug development has continued to escalate at two and one half times the rate of inflation. The cost of introducing a drug to the market was $802 million in 2000 compared with $237 million in 1987 (2 ). As an indirect cost, it takes 7–12 yr for a drug to move through development to the final Food and Drug Administration approval (2 ). Several factors have influenced the escalation in the cost of drug development, including more rigorous approval standards. Regulatory standards are not likely to become less rigorous; therefore, one must look elsewhere to improve the process.