臨床試験モデルの作成とシミュレーションの手順

抄録

In Model-Based Drug Development (MBDD), modeling and simulation is repeatedly performed aiming to develop drugs efficiently in a quantitative manner. Through planning stages of clinical trials, the design is planned, evaluated and decided by the results of the clinical trial simulation updated continuously based on the latest information. For executing a clinical trial simulation, a mathematical model is designed and constructed for various purposes on the basis of three models (i.e., Disease model, Drug model, and Trial model).
It is revised accordingly based on the latest information. The development policy of a drug is determined by triol designs which are planned and evaluated based on the results of the clinical trial simulations. It is necessary for decision makers to consider the uncertainty of the simulation’s results in their decision processes. In this paper, we explain the outline of three models and introduce statistical theories and simulation methods showing examples as a basic theory of pharmacometrics for executing MBDD. Moreover, the decision making process considering uncertain factors is outlined.