Pharmacologic studies in vulnerable populations: Using the pediatric experience
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Updated: Apr 4, 2026

Intraventricular Drug Delivery and Sampling for Pharmacokinetics and Pharmacodynamics Study
Published on: March 31, 2022
Kanecia Zimmerman1, Daniel Gonzalez2, Geeta K Swamy3
1Duke University Medical Center, Duke Clinical Research Institute, 2400 Pratt St, Durham, NC 27705; Department of Pediatrics, Duke University Medical Center, Durham, NC.
Abstract:
Historically, few data exist to guide dosing in children and pregnant women. Multiple barriers to inclusion of these vulnerable populations in clinical trials have led to this paucity of data. However, federal legislation targeted at pediatric therapeutics, innovative clinical trial design, use of quantitative clinical pharmacology methods, pediatric thought leadership, and collaboration have successfully overcome many existing barriers. This success has resulted in improved knowledge on pharmacokinetics, safety, and efficacy of therapeutics in children. To date, research in pregnant women has not been characterized by similar success. Wide gaps in knowledge remain despite the common use of therapeutics in pregnancy. Given the similar barriers to drug research and development in pediatric and pregnant populations, the route toward success in children may serve as a model for the advancement of drug development and appropriate drug administration in pregnant women.
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