Evaluating the Renal Safety of Investigational New Drugs: Where Should We Be Going?

We the authors work in the US Food and Drug Administration (FDA) review division responsible for the therapeutic agents for primary renal disease. We also field consultative inquiries regarding off-target adverse renal effects of drugs intended to treat other diseases. We do neither basic science re...

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Bibliographic Details
Published inClinical pharmacology and therapeutics Vol. 102; no. 3; p. 387
Main Authors Stockbridge, N, Blank, M, Hausner, E A, Thompson, A
Format Journal Article
LanguageEnglish
Published United States 01.09.2017
Subjects
Animals
Drug Design
Drug Evaluation, Preclinical - methods
Drug-Related Side Effects and Adverse Reactions - epidemiology
Drugs, Investigational - administration & dosage
Drugs, Investigational - adverse effects
Humans
Kidney - drug effects
Kidney Diseases - chemically induced
United States
United States Food and Drug Administration
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Summary:We the authors work in the US Food and Drug Administration (FDA) review division responsible for the therapeutic agents for primary renal disease. We also field consultative inquiries regarding off-target adverse renal effects of drugs intended to treat other diseases. We do neither basic science research on renal diseases nor clinical studies of new drugs, but we are professional spectators of both. We offer here our thoughts on the challenge of identifying renal safety signals in the preclinical space and in the earliest phases of clinical development.
ISSN:1532-6535
DOI:10.1002/cpt.745