Author: Kayla Korzekwinski

Thumbnail screenshot of methadone results-at-a-glance summary

Methadone Results-at-a-Glance

Posted on by Kayla Korzekwinski

Read the methadone Results-at-a-Glance summary.

Nearly 20% of children in the United States are classified as obese. These children receive medicines more often than children without obesity, and the doses of medicines they receive are often based on body weight. How obesity impacts the way children process medications was not well understood. The “Use of Physiologically-based Pharmacokinetic Modeling to Inform Dosing of the Opioid Analgesics Fentanyl and Methadone in Children with Obesity” study was conducted to learn how children’s age, obesity status, and genes impact the way their bodies process methadone and fentanyl.

PTN Publications Policy Version 5.0

Posted on by Kayla Korzekwinski

View the Publications Policy Version 5.0.

This PTN Publications Policy applies to information that represents PTN, is supported by PTN, or uses data provided by PTN. Examples of such information includes PTN Publications such as abstracts, manuscripts, slide decks, and texts of oral or other presentations. Additionally, this information can be PTN Public Presentations, such as text for social media or public-facing websites.

Sponsor- vs. FDA-Initiated Changes to Pediatric Clinical Trial Protocols: A Comparison of Associated Participant Burden

Posted on by Kayla Korzekwinski

Therapeutic Innovation & Regulatory Science • February 2025

Access article on PubMed.

Abdel-Rahman S, Sund Z, Alderman C, Abella K, Kennel P, on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.

Risks associated with clinical trial participation are a foremost consideration during protocol development whereas trial-associated burdens receive less focus despite their measurable impact on enrollment and retention. Of late, the U.S. Food and Drug Administration (FDA) has elevated discussions on barriers to research participation resulting from overly burdensome trials. Given the agency’s role in shaping clinical protocol design, this study examined the perceived burden associated with FDA-proposed study changes in the context of pediatric, off-patent, labeling studies.