• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Biosimulation takes center stage in determining pediatric dosing during clinical trial process

Biosimulation takes center stage in determining pediatric dosing during clinical trial process

August 15, 2015
CenterWatch Staff

Biosimulation is playing a growing role in drug development, espe­cially with candidate drugs intended to treat pediatric populations. Re­searchers want to minimize children’s exposure to experimental drugs. Therefore, they increasingly are turn­ing to physiologically-based phar­macokinetic (PBPK) modeling and biosimulation to provide insights into how a candidate drug might behave in younger subjects.

While it is possible to use allome­tric scaling to predict pediatric doses from adult data based on body size, differences in physiology can result in doses that are two or three times greater than necessary in infants.

PBPK modeling predicts more scientifically how a drug will behave in the body by integrating demo­graphic, physiological, biochemical and genetic systems data with drug absorption, metabolism and trans­portation data to simulate in vivo PK in virtual patient populations. This approach recognizes that PK changes with age by including information on how many of the systems parameters change with age. As a result, an anti-asthma drug can be eliminated very slowly in neonates but faster than an adult in a 2-year-old. Certara’s model recommends drug starting doses for children in specific age ranges.

Drug-drug interactions can also vary in magnitude between children and adults. An interaction that is greater than twofold in adults may be insignificant in infants. PBPK models can help to predict these differences.

FDA guidance currently only covers PBPK modeling for pediatric dose selection, but it has many other uses. We were able to demonstrate that the effective exposure for an oral sustained-dose medication would be the same for pediatric and adult pa­tients. We also showed that multiple doses of a drug were equivalent to one extended-release dose.

We expect to see well-validated PK results being increasingly included in pediatric new drug submissions and label extensions.

 

Trevor Johnson is principal scientist at Certara, the Princeton, N.J.-based global biosimulation technology-enabled drug development consultancy.

This article was reprinted from Volume 22, Issue 08, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>

Upcoming Events

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing