Pediatric Research

Pharmacometrics

“The FDA set a target to design 50% of all pediatric trials using simulations by 2015, and 100% by 2020.”

We can help you hit this target.

Our broad expertise spans noncompartmental and population PK/PD modeling and simulation across all phases of development. We have completed hundreds of PK/PD analyses, reporting, and modeling and simulation projects in early and late pediatric clinical research.

Paidion experts have successfully leveraged modeling and simulation to build and optimize winning drug development programs for dozens of industry sponsors, skillfully determining the right dose and dosing interval across all pediatric age groups. We’re excellent at extrapolating pediatric data from prior adult studies, pre-clinical animal data and literature to determine:

  • the types of pediatric patients to be screened,
  • the number of patients needed to demonstrate efficacy or safety, powered to significance levels,
  • and inclusion/exclusion criteria that result in studies that are shorter and less prone to failure.

Paidion Research’s robust pharmacometrics experience provides unprecedented support for regulatory filings, protocol designs and product labeling in pediatric patients.

Our services include:

Population Modeling
  • PK, PK/PD
  • Integrated Population Analysis
  • Dose Selection and Optimization
Trial Simulation
  • Clinical Trial Simulations
  • Scenario Planning
Study Design and Analysis
Consulting Services