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

• Published in: Clinical pharmacology and therapeutics Vol. 102; no. 3; p. 387
• Main Authors: Stockbridge, N, Blank, M, Hausner, E A, Thompson, A
• Format: Journal Article
• Language: English
• 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

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...