@article{4b2b7e07be65497aaf230e2e04fe7ad1,
title = "Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting",
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.",
author = "Sahre, {Martina D.} and Lauren Milligan and Rajanikanth Madabushi and Graham, {Richard A.} and Reynolds, {Kellie S.} and Andre Terzic and Jessica Benjamin and Burckart, {Gilbert J.} and Huang, {Shiew Mei} and Robert Schuck and Thompson, {Aliza M.} and Issam Zineh",
note = "Publisher Copyright: {\textcopyright} 2021 The Authors. Clinical Pharmacology & Therapeutics {\textcopyright} 2021 American Society for Clinical Pharmacology and Therapeutics Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",
year = "2021",
doi = "10.1002/cpt.2151",
language = "English (US)",
journal = "Clinical Pharmacology and Therapeutics",
issn = "0009-9236",
publisher = "Nature Publishing Group",
}