Abstract
The usefulness of model-based drug development using modeling and simulation (M&S) techniques has been recognized recently in Japan. However, few real examples of M&S have been conducted in Japan. This paucity is caused by two factors: 1) there are not so many‘pharmacometricians’who are responsible for planning, conducting and presenting M&S; and 2)the infrastructure required by M&S is not well developed. To address the former problem, well presented textbooks for self-learning are needed for beginners and even for experienced pharmacokineticists with little background of biostatistics, and vice versa. The problem of poor infrastructure for M&S in Japan is more serious. For example, disease progression models for diseases that are considered to show different pathology in Japanese and Caucasians, such as diabetes mellitus, are urgently needed to predict the progression of the disease and to facilitate the development of new drugs in Japan. Pharmacometricians including pharmacokineticists, biostatisticians, and clinical pharmacologists have to collaborate with each other to solve these problems and contribute to the public health of Japan by ensuring development of new effective and safe drug compounds.
