Author: Kayla Korzekwinski

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.

Population Pharmacokinetics of Meropenem Across the Adult Lifespan

Posted on by Kayla Korzekwinski

Clinical Pharmacokinetics • February 2025

Access article on PubMed.

Boutzoukas AE, Balevic SJ, Hemmersbach-Miller M, Winokur PL, Gu K, Chan AW, Cohen-Wolkowiez M, Conrad T, An G, Kirkpatrick CMJ, Swamy GK, Walter EB, Schmader KE, Landersdorfer CB.

This study conducted an opportunistic pharmacokinetic study to evaluate the population pharmacokinetics of meropenem, an antimicrobial commonly used to treat Gram-negative infections in adults of different ages, including older adults, and determined optimal dosing regimens. Meropenem dosing should be based on renal function rather than age. For patients without renal impairment, extended infusion may increase the probability of target attainment.