Home

Physiologically based pharmacokinetic (PBPK) approaches and allometric approach have been applied to in vitro-in vivo extrapolation (IVIVE) of absorption, distribution, metabolism, and excretion (ADME) in the drug development. However, because of their relative diversity and complexity, these methods have been limited in uses. There were several attempts to integrate those methods and information in a single program, however a majority of PBPK softwares are commercial and usually require unnecessarily large amount of in vitro or animal in vivo information which small-sized pharmaceutical companies cannot afford to generate. Thus, we developed a program with a user-friendly platform that can handle complex PBPK models and allometric model with minimal essential information of drug. A number of references which contains PBPK methods for predicting human PK parameters were evaluated and the models which have shown relative robustness and can be performed efficiently with minimum in vitro/in vivo data were chosen, and we integrated those interspersed PBPK methods in a single program. PK parameter can be predicted by integrating the in vitro/in vivo information of drug, and simulation can be performed with predicted PK parameters as users input the trial design. Predicted PK parameters and following simulation result can be exported to excel file for users’ convenience. Dallphin AtoM is a computer program for predicting PK parameter by integrating the in vitro data and animal in vivo data using allometric approach and PBPK approach. We expect this program can help with internal decision for designing next procedures, validation and auto-testing for new model.

Keywords: IVIVE, Pharmacokinetics, PBPK, simulation