Bridging Literature and Real-World Evidence: External Evaluation of Daptomycin Population Pharmacokinetic Models to Advance Precision Dosing in Elderly Patients

Introduction: Daptomycin is a key antibiotic for multidrug-resistant Gram-positive infections, but its substantial inter-individual pharmacokinetic variability and exposure-related efficacy and toxicity make optimal dosing challenging, particularly in elderly patients. Age-related changes in renal function may further alter daptomycin exposure, increasing the risk of underexposure or toxicity. Population pharmacokinetic (PopPK) models provide the foundation for model-informed […]

Model-Integrated Evidence for Delafloxacin: Minimal PBPK-PD Simulations and Network Meta-Analysis to Support Urinary Tract Infection Indication Development

Introduction: Delafloxacin is a novel anionic fluoroquinolone with broad-spectrum activity against aerobic and anaerobic Gram-positive and Gram-negative pathogens, including several clinically relevant resistant organisms. Although delafloxacin has primarily been developed and approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, its antibacterial spectrum, dual intravenous and oral formulations, and renal elimination […]