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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| Published in | Clinical pharmacology and therapeutics Vol. 102; no. 3; p. 387 |
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| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
01.09.2017
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| Subjects | |
| Online Access | Get more information |
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| Abstract | 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. |
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| AbstractList | 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. |
| Author | Blank, M Hausner, E A Thompson, A Stockbridge, N |
| Author_xml | – sequence: 1 givenname: N surname: Stockbridge fullname: Stockbridge, N organization: US Food and Drug Administration Center for Drug Evaluation and Research, Division of Cardiovascular and Renal Products, Silver Spring, Maryland, USA – sequence: 2 givenname: M surname: Blank fullname: Blank, M organization: US Food and Drug Administration Center for Drug Evaluation and Research, Division of Cardiovascular and Renal Products, Silver Spring, Maryland, USA – sequence: 3 givenname: E A surname: Hausner fullname: Hausner, E A organization: US Food and Drug Administration Center for Drug Evaluation and Research, Division of Cardiovascular and Renal Products, Silver Spring, Maryland, USA – sequence: 4 givenname: A surname: Thompson fullname: Thompson, A organization: US Food and Drug Administration Center for Drug Evaluation and Research, Division of Cardiovascular and Renal Products, Silver Spring, Maryland, USA |
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| Copyright | Published 2017. This article is a U.S. Government work and is in the public domain in the USA. |
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| Title | Evaluating the Renal Safety of Investigational New Drugs: Where Should We Be Going? |
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