The development of a new drug is a high risk and costly activity that involves multiple decisions and tradeoffs. Model-Based Drug Development Approach (MBDDA) allows combining proprietary data on a specific compound with literature data of its likely competitors and, thereby, represents powerful tool for managing risks concerning dose selection, efficient and effective trial design, and "go/no-go" decisions. MBDDA enables us to combine whole organism description specified by PBPK model, peculiarities of drug distribution and delivery given by systemic model, detailed description of inter- and intra- cellular processes assigned by kinetic model and quantitative dose-effect relationship preset by PK/PD model.

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