Model-Informed Drug Development (MIDD) encompasses a variety of mathematical modelling methodologies to accelerate drug development and streamline regulatory approvals. Some of the modeling methods are utilized in a specific stage of the development process, while the physiologically-based pharmacokinetic (PBPK) modeling has found applications in every stage from early discovery through post-approval changes. PBPK model-based predictions are widely utilized by investigators to predict first-in-human dose, formulations designing, ADME/QSAR predictions, pharmacokinetics predictions in special populations (such as pediatrics, pregnant, and disease states). A PBPK model also allows to evaluate drug-drug interactions in a wide range of mechanistic and tissue exposure predictions in early stage.

The webinar will provide an overview of PBPK modeling and its applications, supported by case studies in specific areas of the drug development process.

• Principles of PBPK modeling.
• Current knowledge and limitations of PBPK models.
• Applications of PBPK modeling in early discovery, formulation development, and evaluation of drug-drug interaction potential.
• Impact of PBPK modeling on generic drug product development.

Viera Lukacova, Ph.D.

Dr. Viera Lukacova is the Chief Scientist at Simulations Plus, Inc. Over the last nearly two decades, she has been contributing to the research and development of GastroPlus®, DDDPlus™, and MembranePlus™ software packages widely used throughout the pharmaceutical industry in early drug development, formulation, pre-clinical, and clinical research; with the main focus on mechanistic absorption and PBPK modeling.

She is also involved in modeling studies helping companies with their drug development programs in early discovery stage, formulation development, clinical pharmacology applications, and interactions with regulatory agencies. She authored a number of papers in computational chemistry, basic research of transport of small molecules through artificial membranes, and pharmacokinetic and pharmacodynamic modeling in peer-reviewed journals and served as a reviewer of publications in the same areas.”