Developmental changes in children can affect the disposition and clinical effects of a drug,
indicating that scaling an adult dose simply down per linear weight can potentially lead to …

During the past few decades, the science of toxicology has been undergoing a
transformation from observational to predictive science. New approach methodologies …

Extrapolation of pharmacokinetic (PK) parameters from in vitro or in vivo animal to human is
one of the main tasks in the drug development process. Translational approaches provide …

Drug‐induced kidney injury, a major cause of acute kidney injury, results in progressive
kidney disease and is linked to increased mortality in hospitalized patients. Primary injury …

Abstract Evaluation of drug–drug interaction (DDI) risk is vital to establish benefit–risk
profiles of investigational new drugs during drug development. In vitro experiments are …

Indoxyl sulfate (IxS), a highly albumin-bound uremic solute, accumulates in chronic kidney
disease (CKD) due to reduced renal clearance. This study was designed to specifically …

Enavogliflozin is a sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor approved
for clinical use in South Korea. As SGLT2 inhibitors are a treatment option for patients with …

Development of submodels of organs within physiologically-based pharmacokinetic (PBPK)
principles and beyond simple perfusion limitations may be challenging because of …

Despite extensive breakthroughs in chemistry, molecular biology, and genetics in the last
decades, the success rates of drug development projects remain low. To improve …

With an increasing need to incorporate new approach methodologies (NAMs) in chemical
risk assessment and the concomitant need to phase out animal testing, the interpretation of …