Specific areas of expertise:
Population PK Modeling:
- Application of nonlinear mixed effect modeling methods to describe pharmacokinetics
of small molecules and biologics, including extensive experience with target-mediated drug disposition models;
- Population analyses to support dosing regimens and label claims, to describe
pharmacokinetics of drugs in special populations (elderly, with renal or hepatic impairment,
pediatric, etc.) in lieu of or in addition to the special populations studies; to predict
exposure for PK-PD analyses;
- Model-based simulations to design/optimize dosing regimens satisfying specific
requirements either for the overall exposure or for the specific shape of the concentration-time profiles.
Design, Analysis and Simulations of QTc Prolongation Trials.
Design, Analysis and Simulations of IVIVC Trials:
- Development of algorithms and software tools for IVIVC modeling
(one of inventors and developers of PDx-IVIVC®);
- Development of a Level A IVIVC.
Modeling and Drug Development Experience in the Variety of Therapeutic Areas, Including:
- Inflammatory and Auto-immune Diseases;
- Central and peripheral nervous system;
- Pain / Analgesia;
- Infectious Diseases;
- Metabolic Diseases;
- Musculoskeletal Diseases;