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- Title
Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting.
- 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
- Abstract
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.
- Subjects
UNITED States. Food &; Drug Administration; PHARMACEUTICAL chemistry; CLINICAL pharmacology; DRUG development; KIDNEY physiology; CHRONIC kidney failure
- Publication
Clinical Pharmacology & Therapeutics, 2021, Vol 110, Issue 2, p285
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1002/cpt.2151