Host: The Japanese Society of Toxicology
Name : The 47th Annual Meeting of the Japanese Society of Toxicology
Date : 2020 -
In the new drug discovery, it has been general to perform the quantitative analysis of drug pharamacokinetics using mathematical modeling. Physiologically-based pharamacokinetic (PBPK) model, which directly uses physiological and anatomical parameters such as human blood flow and organ volume, has been focused in recent years. The parameters of PBPK model correspond a certain physiological and physicochemical meaning. Theses parameters values have inter-individual variability by genetic polymorphism, ethnicity, individual difference, etc. The accumulation of those variability may cause unexpected blood concentraion-time profile, pharmacological and toxicological effects of drugs It is difficult to detect such unexpected results in the early stage of clinical study because of the insufficient number of subject. On the other hand, the information of inter-individual variability of PBPK model parameters is obtained. We established virtual clinical study (VCS), which uses computational simulation and prediction of drug pharamacokinetics, pharmacological and toxicological effects in the specific population with virtual patients generated by the variability information. In this presentation, I will introduce some examples of VCS to predict results of actual clinical studies.
