Precision Dosing Using PBPK Modeling

On-Demand Webinar

Precision dosing― the right dose, for the right patient, at the right time― is crucial to providing patients with the most efficacious medications with minimal probability of adverse events. One key step towards achieving the delivery of individualized dosing is testing potential dosing regimens in a patient’s ‘virtual twin.’ The other key step is to have as much drug information as possible. Achieving these key steps requires generating a large amount of data. A computer modeling and simulation platform is needed to assimilate these data together to study their interactions.

Some clinical trials only reveal the “average response” to a drug in a particular population. Yet, individual responses of patients can vary significantly due to their genetics, physiology and ethnicity. In a systems pharmacology paradigm, the Certara framework of physiologically based pharmacokinetic (PBPK) models integrates patient characteristics and drug parameters and predicts the drug pharmacokinetics properties using in vitro- in vivo extrapolation (IVIVE) techniques.

Learn how PBPK models and IVIVE can be used as tools for precision dosing. Dr. Devendra Pade discussed key differences between ethnic groups and diseased populations versus healthy individuals and illustrated how these differences affect drug pharmacokinetics.

About our Speaker

Devendra Pade, Research Scientist, Certara. Devendra Pade is a Research Scientist in Certara’s modeling and simulation group. He received his PhD in the Prediction of Oral Drug Absorption and Pre-Clinical Pharmacokinetics with the Stavchansky group from The University of Texas at Austin. Since joining Simcyp in 2009, he has worked on various projects in PBPK modeling with a major interest in oral drug absorption and development of animal PBPK models for preclinical species such as rat, beagle dog, mouse and cynomolgus monkey. As part of the oral absorption team, he was also involved with the development of the bariatric surgery models to evaluate the impact of various weight loss surgeries on the pharmacokinetics of different drugs.

Precision dosing― the right dose, for the right patient, at the right time― is crucial to providing patients with the most efficacious medications with minimal probability of adverse events. One key step towards achieving the delivery of individualized dosing is testing potential dosing regimens in a patient’s ‘virtual twin.’ The other key step is to have as much drug information as possible. Achieving these key steps requires generating a large amount of data. A computer modeling and simulation platform is needed to assimilate these data together to study their interactions.

Some clinical trials only reveal the “average response” to a drug in a particular population. Yet, individual responses of patients can vary significantly due to their genetics, physiology and ethnicity. In a systems pharmacology paradigm, the Certara framework of physiologically based pharmacokinetic (PBPK) models integrates patient characteristics and drug parameters and predicts the drug pharmacokinetics properties using in vitro- in vivo extrapolation (IVIVE) techniques.

Learn how PBPK models and IVIVE can be used as tools for precision dosing. Dr. Devendra Pade discussed key differences between ethnic groups and diseased populations versus healthy individuals and illustrated how these differences affect drug pharmacokinetics.