Computer Models Combine Growth and Disease Patterns with Real-Time Patient Data for Precision Drug Dosing

Published September 2015
Clinical Pharmacology & Therapeutics

Computer models maintained by Cincinnati Children’s pharmacology researchers now use real-time patient data to give pediatricians worldwide better information on ideal drug dosing strategies for children.

These new models, described in the September 2016 issue of Clinical Pharmacology & Therapeutics, work effectively whether the patients are tiny premature infants, rapidly growing toddlers, or adolescents.

Alexander Vinks, PharmD, PhD, director of Clinical Pharmacology, worked with colleagues Tsuyoshi Fukuda, PhD, and Chie Emoto, PhD, to describe how computer modeling applies to pharmacokinetics (how a drug moves within a body) and to pharmaco-dynamics (how a drug affects the body).

“This approach is very different from the current paradigm where for most drugs, we give incremental doses but don’t have easy markers that we can use to tailor doses over time,” Vinks says. “With pharmacokinetics modeling, we can track how growth spurts reflect on the behavior of the drug in the child, capture these growth patterns in computer models, and turn that into management information to predict effective doses."

The computer models serve as a “flight control center” that can allow doctors to adjust doses according to population-based models and real-time patient data. Such data can include age, gender, body weight, diagnosis, genotype, organ function, race, ethnicity, blood concentration levels, and enzyme functions.

Modeling also can support clinical study design and regulatory approval, processes still based on standard doses, safety and efficacy in average patients, Vinks says.

Eventually, he predicts that rising use of improved computer models will help produce “a new cadre of investigators well versed in pediatric clinical pharmacology, pharmacokinetics and pharmacogenetics."

Fig A: PK/PD Model-Based Guidance
Click image to view caption.

Citation

Photo of Alexander A. Vinks, PharmD, PhD, FCP.

Alexander Vinks, PharmD, PhD

Photo of Tsuyoshi Fukuda, PhD.

Tsuyoshi Fukuda, PhD