R Shiny apps allow for dynamic, interactive, real-time integration of knowledge within a drug-development program to support decision making. Here, an R Shiny app was used to explore the pharmacokinetic and pharmacodynamic effects of different dosing regimens of the anti IL-17 human mAb CosentyxÂ® (secukinumab) in pediatric patients. Secukinumab has been studied and approved to treat psoriasis in adult patients. Models which describe the dose-exposure-response relationships in adults (Lee et al., Clin Pharmacol Ther, 2019 and FDA, Medical Reviews BLA 125504, 2015) were used in the mrgsolve simulation package to explore these relationships in pediatric patients. The prior adult knowledge, used in conjunction with the computational infrastructure leveraged through R, the Shiny app, mrgsolve, and Rcpp, allows researchers to explore various dosing regimens in a difficult-to-study patient population. The tools and approaches described here have been routinely used to support regulatory interactions (ex. PIP) involving pediatric dosing.
Jeannine Fisher
Metrum Research Group
Leveraging multiple R tools to make effective pediatric dosing decisions
R Shiny apps allow for dynamic, interactive, real-time integration of knowledge within a drug-development program to support decision making. Here, an R Shiny app was used to explore the pharmacokinetic and pharmacodynamic effects of different dosing regimens of the anti IL-17 human mAb CosentyxÂ® (secukinumab) in pediatric patients. Secukinumab has been studied and approved to treat psoriasis in adult patients. Models which describe the dose-exposure-response relationships in adults (Lee et al., Clin Pharmacol Ther, 2019 and FDA, Medical Reviews BLA 125504, 2015) were used in the mrgsolve simulation package to explore these relationships in pediatric patients. The prior adult knowledge, used in conjunction with the computational infrastructure leveraged through R, the Shiny app, mrgsolve, and Rcpp, allows researchers to explore various dosing regimens in a difficult-to-study patient population. The tools and approaches described here have been routinely used to support regulatory interactions (ex. PIP) involving pediatric dosing.