Mark your calendars for "Pediatric Dose Selection," a workshop hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).

Register to Attend View the Agenda Learn More About M-CERSI

Scheduled for Oct. 22-23, 2020, "Pediatric Dose Selection" aims to address the incomplete information currently available on determining dose selection in the pediatric population.

Important Event Information
Date: Oct. 22-23, 2020
Time: 10:00 a.m. - 2:00 p.m. (Oct. 22)
10:00 a.m. - 12:35 p.m. (Oct. 23)
Location: This is an online event. Information to access the webinar will be emailed to all attendees after registration is completed.
Registration: Online Registration Available Here

About the Event:

Dose selection for new drug products for pediatric patients remains a critical part of pediatric drug development. The statement made in 2010 by Darrell Abernethy and Burckart is still true today: “Selection of a drug dose in pediatrics is generally based on no or incomplete pharmacokinetic data. Traditionally, allometric, or scaling, techniques have been used; however, they have inherent limitations and may not make optimal use of the drug-specific clinical pharmacokinetic information that is available. Modeling is a tool that holds promise. The future challenge is to create a structured approach to determining pediatric doses for new therapeutic agents.”1

Pediatric dose selection has been identified as one of the major reasons for failures in pediatric drug development trials.2 This is particularly concerning at a time when the FDA is encouraging the extension of drug development trials into neonates whenever possible.

Older children and adolescents also present challenges for dosing in new drug development. The place and method of allometric scaling for dosing for children has been debated, as have other means of filling the gaps of studies that ethically cannot be conducted in children, including bioequivalence, drug-drug interactions3, and renal and hepatic impairment studies.

As stated in 2010, model-informed drug development holds considerable promise for making pediatric dose selection a science. New approaches to MIDD are emerging, such as the use of Bayesian approaches, and would benefit from a robust discussion in a public workshop.

Workshop Objectives:

This workshop is intended for clinicians, drug developers, and regulators. The objectives of this workshop are to:

  1. Review the current methods of pediatric dose selection.
  2. Discuss how to address the gaps in pediatric dose selection that occur because of the inability to perform studies in pediatric patients.
  3. Evaluate future approaches to pediatric dose selection in all pediatric patient populations.

For More Information:

More information about this event, including details about registration and an agenda, is available on this website.

If you have any additional questions about this event, please contact cersi@umd.edu.

References:

1 Abernethy DR, Burckart GJ. Pediatric dose selection. Clinical Pharmacology & Therapeutics 2010; 87:270-1.

2 Momper JD, Mulugeta Y, Burckart GJ. Failed Pediatric Drug Development Trials. Clinical Pharmacology & Therapeutics 2015; 98:245-51.

3 Salerno SN, Burckart GJ, Huang SM, Gonzalez D. Pediatric Drug-Drug Interaction Studies: Barriers and Opportunities. Clinical Pharmacology & Therapeutics 2019; 105:1067-1070.

Acknowledgement:

This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling $5,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.