Automated Prediction of First-in-man Dosing Using Pre-clinical PK Data

On-Demand Webinar

Humans differ from commonly used pre-clinical model organisms (rats, dogs, monkeys) in terms of their biochemistry, physiology, and anatomy. Predicting a drug’s pharmacokinetic (PK) profile in humans using animal PK data must account for these differences. Allometric scaling is used to predict human PK parameters based on animal data. While allometric scaling has been used in drug development for many years, it has historically been a very complicated and laborious process.

Certara scientists have developed a novel, fully automated application that can support critical decision making when designing a first-in-man clinical study based on pre-clinical data. In this webinar, Dr. Serge Guzy and Tinh Nguyen demonstrated how this application uses a population PK modeling approach to fit input data from multiple species, calculate PK model parameters for each species, and then extrapolate to humans based on a pre-defined allometric scaling equation. They then showed how the application can calculate optimal dosing scenarios based on user-defined drug exposure thresholds.

About our speakers

Serge Guzy, President & CEO, Pop-Pharm. Serge Guzy is currently Professor (affiliate) at the University of Maryland, Professor (adjunct) at the University of Minessota, visiting Professor at the school of medicine (Jerusalem) and adjunct associate professor at SUNY Buffalo. He is involved in both research and teaching at all these academic institutions. Serge is also president and CEO of POP_PHARM, a company that signed a strategic alliance with Certara to develop the Phoenix population software and provide professional training services to assist Phoenix NLME users. Serge is the co-developer of the MCPEM algorithm that is today implemented in almost all population modeling software.

Tinh Nguyen, Sr. Technical Manager, Certara. Tinh Nguyen is a Sr. Technical Manager in Certara’s Deployment Services group. He joined Certara in July 2011 and led the development of custom plug-ins and applications. Before joining Certara, he spent fourteen years at Merck Research Lab IT as a project manager mainly supporting Merck PPDM group. He hold the Project Management Professional (PMP) and Certified Scrum Master (CSM) certifications. He graduated with the MS in computer science at Villanova University in 1991.

Humans differ from commonly used pre-clinical model organisms (rats, dogs, monkeys) in terms of their biochemistry, physiology, and anatomy. Predicting a drug’s pharmacokinetic (PK) profile in humans using animal PK data must account for these differences. Allometric scaling is used to predict human PK parameters based on animal data. While allometric scaling has been used in drug development for many years, it has historically been a very complicated and laborious process.

Certara scientists have developed a novel, fully automated application that can support critical decision making when designing a first-in-man clinical study based on pre-clinical data. In this webinar, Dr. Serge Guzy and Tinh Nguyen demonstrated how this application uses a population PK modeling approach to fit input data from multiple species, calculate PK model parameters for each species, and then extrapolate to humans based on a pre-defined allometric scaling equation. They then showed how the application can calculate optimal dosing scenarios based on user-defined drug exposure thresholds.