Utility of Modeling and Simulations in Drug Development: Contrasting Japan, US and UK Descriptions of PBPK Modeling from Package Inserts.

Physiologically based pharmacokinetic (PBPK) modeling is a mathematical method for predicting drug pharmacokinetics based on individual physiological information, and its usefulness has been attracting attention in recent years. This study aimed to investigate and compare the extent to which PBPK models are utilized in drug package inserts in Japan, the United States, and Europe. We searched the official websites of the PMDA, FDA, and EMA to examine the number and content of drugs that mention the use of PBPK modeling as of 2024. Furthermore, we compared the consistency and detail of the descriptions between Japan, the United States, and Europe. As a result, 38 drugs in Japan listed PBPK modeling, many of which were related to drug-drug interactions. Compared with Europe, there were no complete matches and only seven partial matches, while compared with the United States, there were two complete matches and 24 partial matches. A comparison of the details of the 24 partial matches revealed a tendency for Japanese package inserts to be more detailed. PBPK model analysis has become increasingly important in recent drug development, and Japan in particular has a tendency to provide more detailed information on package inserts. This study suggests the potential for further utilization of PBPK models in the field of clinical pharmacology.