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

Martina D. Sahre; Lauren Milligan; Rajanikanth Madabushi; Richard A. Graham; Kellie S. Reynolds; Andre Terzic; Jessica Benjamin; Gilbert J. Burckart; Shiew Mei Huang; Robert Schuck; Aliza M. Thompson; Issam Zineh

doi:10.1002/cpt.2151

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

Martina D. Sahre, Lauren Milligan, Rajanikanth Madabushi, Richard A. Graham, Kellie S. Reynolds, Andre Terzic, Jessica Benjamin, Gilbert J. Burckart, Shiew Mei Huang, Robert Schuck, Aliza M. Thompson, Issam Zineh

Cardiovascular Medicine

Research output: Contribution to journal › Comment/debate › peer-review

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.

Original language	English (US)
Pages (from-to)	285-288
Number of pages	4
Journal	Clinical pharmacology and therapeutics
Volume	110
Issue number	2
DOIs	https://doi.org/10.1002/cpt.2151
State	Published - Aug 2021

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)

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10.1002/cpt.2151

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Sahre, M. D., Milligan, L., Madabushi, R., Graham, R. A., Reynolds, K. S., Terzic, A., Benjamin, J., Burckart, G. J., Huang, S. M., Schuck, R., Thompson, A. M., & Zineh, I. (2021). Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting. Clinical pharmacology and therapeutics, 110(2), 285-288. https://doi.org/10.1002/cpt.2151

Evaluating Patients With Impaired Renal Function During Drug Development : Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting. / Sahre, Martina D.; Milligan, Lauren; Madabushi, Rajanikanth et al.

In: Clinical pharmacology and therapeutics, Vol. 110, No. 2, 08.2021, p. 285-288.

Research output: Contribution to journal › Comment/debate › peer-review

Sahre, MD, Milligan, L, Madabushi, R, Graham, RA, Reynolds, KS, Terzic, A, Benjamin, J, Burckart, GJ, Huang, SM, Schuck, R, Thompson, AM & Zineh, I 2021, 'Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting', Clinical pharmacology and therapeutics, vol. 110, no. 2, pp. 285-288. https://doi.org/10.1002/cpt.2151

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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.",

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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

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