USA – FDA shares research to improve dose selection in pediatric drug development

Dose selection is a significant challenge in pediatric drug development; commonly used renal function equations can overestimate glomerular filtration rates and result in inaccurate predictions of drug elimination.

In a Regulatory Science in Action article, scientists from the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) shared findings about how adjustments to the estimated glomerular filtration rate (eGFR) equations could help improve the accuracy of predicted renal function in pediatric drug studies.

“Although the clearance of renally eliminated drugs might be overestimated when using creatinine-based renal function equations – especially for pediatric patients with low levels of serum creatinine – well-reasoned adjustments to methods of calculating eGFR values may improve the accuracy of predicted parameters,” CDER officials wrote. “Equations based on cystatin C levels or a combination of multiple renal biomarkers might be productive in this regard.”…