Abstract
Although the expenses involved in brining medicinal products to the market are increasing each year, the success rate of clinical development has not increased significantly. Considering its situation, the necessity of improving productivity of drug development is becoming the common concept among pharmaceutical companies. Related to the industrial trend, FDA has issued the“White Paper”in 2004 and 2006, which covers biomarker, rationalization of clinical trial design, and model-based drug development (MBDD) as methods to increase productivity of drug development.
By showing the relationship between pharmacokinetics, pharmacological action (biomarker) and drug efficacy; clarifying their relationships; and developing mathematical models from their relationship, the results obtained may allow us to assess the mechanisms of drug actions in human scientifically and quantitatively and to predict what would happen by simulation technique. These are the bases of modeling and simulation (M&S)and MBDD.
“Population PK”and“population PK-PD”have become be known as“everyday terms”since they have been widely used in many guidelines, academic societies, seminars, and journals. There is no doubt that M&S or MBDD will become indispensable in drug development. In this paper, the roles, assessment and usage of M&S or MBDD in clinical drug development are discussed.
