Scientific and Regulatory Policy Committee Points to Consider: Integration of Clinical Pathology Data With Anatomic Pathology Data in Nonclinical Toxicology Studies.

Integrating clinical pathology data with anatomic pathology data is a common practice when reporting findings in the context of nonclinical toxicity studies and aids in understanding and communicating the nonclinical safety profile of test articles in development. Appropriate pathology data integration requires knowledge of analyte and tissue biology, species differences, methods of specimen acquisition and analysis, study procedures, and an understanding of the potential causes and effects of a variety of pathophysiologic processes. Neglecting these factors can lead to inappropriate data integration or a missed opportunity to enhance understanding and communication of observed changes.

Scientific and Regulatory Policy Committee Points to Consider: Integration of Clinical Pathology Data With Anatomic Pathology Data in Nonclinical Toxicology Studies.

Integrating clinical pathology data with anatomic pathology data is a common practice when reporting findings in the context of nonclinical toxicity studies and aids in understanding and communicating the nonclinical safety profile of test articles in development. Appropriate pathology data integration requires knowledge of analyte and tissue biology, species differences, methods of specimen acquisition and analysis, study procedures, and an understanding of the potential causes and effects of a variety of pathophysiologic processes. Neglecting these factors can lead to inappropriate data integration or a missed opportunity to enhance understanding and communication of observed changes.

A Review of Specific Biomarkers of Chronic Renal Injury and Their Potential Application in Nonclinical Safety Assessment Studies.

A host of novel renal biomarkers have been developed over the past few decades which have enhanced monitoring of renal disease and drug-induced kidney injury in both preclinical studies and in humans. Since chronic kidney disease (CKD) and acute kidney injury (AKI) share similar underlying mechanisms and the tubulointerstitial compartment has a functional role in the progression of CKD, urinary biomarkers of AKI may provide predictive information in chronic renal disease. Numerous studies have explored whether the recent AKI biomarkers could improve upon the standard clinical biomarkers, estimated glomerular filtration rate (eGFR), and urinary albumin to creatinine ratio, for predicting outcomes in CKD patients.