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.

Application of MBDDA to drug development allows:

• to facilitate and automatize the process of data management and interpretation;
• to improve and formalize the process of the decision making during drug development.
• to extend analysis of internally generated data at the expense of all available public literature. data integrated in mathematical model.
• to use the model approach for a drug development (Model-based drug development).
• to identify and study drug action mechanisms and drug side effects.
• to procces drug safety methods and strategies.

To integrate heterogeneous clinical and biomedical data, design a program that fully explores possible treatment regimens and clinical trial sequences for the highest value clinical development strategy and make predictive hypothesis for every stage of drug development the Institute for Systems Biology SPb  proposes to employ MBDDA consisting of applying either one by one or in combination following modelling techniques:

• Pharmacokinetic/Pharmacodynamic (PK/PD) modeling
• Compartment and non compartment approach to PK/PD modeling
• Physiologically based pharmacokinetic (PBPK) modeling
• Mechanism based PK/PD modelling
• Population PK/PD analysis
• Analysis of bioequivalence and bioavailability
• Kinetic modeling of biochemical, signal transduction and regulatory pathways
• Kinetic modeling to unravel therapeutic and side effects of the drug
• Molecular dynamics and Docking
• Our innovation: Systemic modeling of transfer systems of organism (blood circulation, lymphatic system and digestive systems)
• Development of advisory software on the basis of the models constructed.

On the basis of MBDDA we have developed quantitative description of following diseases:

• Asthma
• Breast cancer
• Diabetes
• Pheumonia
• Tuberculosis
• Osteoarthritis
• Osteoporosis
• Cronic inflamation desseases
• Heart attacks and clot formation
• Hepatitis (HCV)
• AIDS