Evaluation of the intact nephron hypothesis using optimal design methodology

Introduction: Renal dose adjustment generally assumes a linear relationship between renal drug clearance (CLR) and glomerular filtration rate (GFR). The theory underpinning this practice is the intact nephron hypothesis (INH) [1]. Studies designed to test INH do not generally consider optimisation of design factors like sampling time, values of GFR, sample size, etc. [2]. The […]

Evaluation of study designs to test the intact nephron hypothesis

Introduction: Renal dose adjustment generally assumes a linear relationship between renal drug clearance (CLR) and glomerular filtration rate (GFR). The theory underpinning this practice is the Intact Nephron Hypothesis (INH) [1]. A recent review by our group suggested that the INH may not be a suitable general model for renal drug clearance, particularly for drugs that […]

Study designs for renal drug studies

Introduction: Renal dose adjustment generally assumes a linear relationship between renal drug clearance and glomerular filtration rate (GFR). The theory underpinning this practice is the Intact Nephron Hypothesis (INH) [1], which assumes that nephrons are either completely functional (intact) or completely non-functional. There is a growing body of evidence to suggest that a non-linear relationship […]