Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting

Patients with multiple chronic conditions, including more advanced chronic kidney disease (CKD), are often excluded from clinical trials, creating challenges in deriving appropriate dosing information and labeling. This article summarizes the May 7, 2019, US Food and Drug Administration Pharmaceutic...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2021-08, Vol.110 (2), p.285-288
Main Authors: Sahre, Martina D., Milligan, Lauren, Madabushi, Rajanikanth, Graham, Richard A., Reynolds, Kellie S., Terzic, Andre, Benjamin, Jessica, Burckart, Gilbert J., Huang, Shiew‐Mei, Schuck, Robert, Thompson, Aliza M., Zineh, Issam
Format: Article
Language:English
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Summary:Patients with multiple chronic conditions, including more advanced chronic kidney disease (CKD), are often excluded from clinical trials, creating challenges in deriving appropriate dosing information and labeling. This article summarizes the May 7, 2019, US Food and Drug Administration Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting, which solicited expert opinions on how to enroll patients with more advanced CKD into clinical trials as well as the assumptions behind and different approaches of exposure‐matching.
ISSN:0009-9236
1532-6535
DOI:10.1002/cpt.2151