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Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
Author(s) -
Sahre Martina D.,
Milligan Lauren,
Madabushi Rajanikanth,
Graham Richard A.,
Reynolds Kellie S.,
Terzic Andre,
Benjamin Jessica,
Burckart Gilbert J.,
Huang ShiewMei,
Schuck Robert,
Thompson Aliza M.,
Zineh Issam
Publication year - 2021
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.2151
Subject(s) - clinical pharmacology , medicine , clinical trial , dosing , advisory committee , kidney disease , intensive care medicine , food and drug administration , drug development , drug , pharmacology , alternative medicine , regulatory science , clinical research , renal function , pathology , political science , public administration
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.