Assessment of renal injury in vivo.
The ICH S7A (Safety Pharmacology for Human Pharmaceuticals) guidelines specify that potential adverse pharmacologic effects of a test substance on renal function should be evaluated in supplemental studies when there is a cause for concern (ICH, 2001). For the most part, this can easily be accomplished by examination of the appropriate analytes in urine and blood collected as part of the routine preclinical safety studies. This review will serve as an overview of the selection, interpretation and limitations of standard clinical pathology methods (serum chemistry and urinalysis) for assessment of renal function in such studies, as well as provide some information on emerging biomarkers of renal function.
Emeigh Hart
Susan G
SG
Genaera Corporation, 5110 Campus Drive, Plymouth Meeting, PA 19462, USA. shart@genaera.com
D000818:Animals; D004353:Drug Evaluation, Preclinical / Q000379:methods* / Q000639:trends; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007668:Kidney / Q000187:drug effects* / Q000502:physiology; D007677:Kidney Function Tests / Q000379:methods; D010338:Pathology, Clinical / Q000379:methods* / Q000639:trends; D018570:Risk Assessment; D016482:Urinalysis / Q000379:methods