Nephrotoxicity During Drug Development

A new review of this subject entitled Detection and Management of Nephrotoxicity during Drug Development has been recently published in Expert Opinion on Drug Safety. The article has been available ahead of print on-line since May 22, 2012.  The authors are members of Renal Safety Expert Group at Roche pharmaceutical company and have many years of combined experience in nephrology, drug development and drug safety.  Previous reviews of the subject have focused on acute kidney injury (AKI) and do not distinguish between different causes of AKI such as ischemia, sepsis or nephrotoxins.  The article by Loghman-Adham et al. is is one of the first articles that specifically addresses drug-induced nephrotoxicity (DIN) and provides practical guidance for risk mitigation and early detection of DIN during all phases of drug development. The application of biomarkers of nephrotxicity is discussed and there are a number of useful tables and figures that provide practical information on how to diagnose and manage DIN.  For complete disclosure, I am one of the authors of this paper.  Below is a link to the journal and the abstract of the article.

Reviewed  by Mahmoud Loghman-Adham, MD

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