Presentation Information
[SS09-01]A Century of MIDD and Future Perspectives of QSP
*Shinichi Tsuchiwata1 (1. Pfizer R&D Japan (Japan))
Keywords:
MIDD,QSP,Virtual Population,Digital Twin
One hundred years have passed since the one-compartment model, which considers the human body as a single compartment to express the time-course of blood drug concentration, was proposed in 1924. Today, empirical models such as the Pharmacokinetic-Pharmacodynamic (PK-PD) model and Exposure-Response (E-R) model are employed to describe the profiles of drugs in the body and their various effects related to their efficacy and safety. Particularly in recent years, Model Informed Drug Development (MIDD) approach, which harness these mathematical and statistical models at various stages and for various purposes, have become widespread to enhance productivity and the success rate of drug development.On the other hand, another trend involves the application of mechanistic models to clinical drug development. These include Physiologically based Pharmacokinetic (PBPK) model and Quantitative Systems Pharmacology (QSP) model. These models integrate detailed in vitro/in vivo information about the functions of organs, tissues, and cells within the body, the behavior and characteristics of various substances involved, and their interactions with drugs. QSP is anticipated to provide insights unattainable from empirical models by quantitatively modeling the complex physiological systems of the human body. Future advancements may enable the prediction of drug effects by administering new drugs to virtual patients on computer systems or through iterative trials using digital twin patient, who possess identical biological profiles to an actual patient, to offer optimal treatment choices for this patient. This presentation will introduce the historical evolution and prospects of utilizing mathematical-biological models in drug development.