Objectives: Ibrexafungerp is a triterpenoid antifungal agent approved in the US in adult and post-menarchal pediatric females for the treatment…
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Female contraceptive cover duration for miltefosine-containing regimens for the treatment of leishmaniasis
Introduction: Miltefosine is the only approved oral therapy for leishmaniasis and remains a key treatment for visceral leishmaniasis (VL), post-kala-azar…
Read moreDefining site-relevant PK/PD targets for nemonoxacin dosing in Streptococcus pneumoniae-associated community-acquired pneumonia through a translational PK/PD approach
Objectives Nemonoxacin is a novel non-fluorinated quinolone demonstrating potent antibacterial activity against Streptococcus pneumoniae, the primary pathogen in community-acquired pneumonia…
Read moreMINIMAL-PBPK URINARY MODEL AND FRAMEWORK FOR INVESTIGATION OF NITROFURANTOIN, CIPROFLOXACIN AND FOSFOMYCIN EFFECT ON ESCHERICHIA COLI IN MICROFLUIDIC-BASED HOLLOW FIBER INFECTION MODEL
INTRODUCTION Antimicrobial resistance continues to rise globally [1], yet research and development in anti‑infective therapeutics face persistent hurdles, reflected in…
Read moreOPTIMISING SAMPLING DESIGN TO ENHANCE PHARMACOKINETIC EVALUATION OF COLISTIN IN NEONATES
Background and Objectives: Gram-negative bacteria (GNB) is the most common cause of early onset sepsis (53%) and late onset neonatal…
Read moreA framework for drug safety assessment based on target affinity, drug exposure and plasma protein binding – dissecting FDA drug-induced cardiotoxicity data from a translational pharmacology perspective
Introduction: Cardiac safety assessment is an integrated part of drug discovery and development. Drug candidates with risk of adversely affecting…
Read moreA Whole-Body PBPK Model to Quantify Organ-Specific Biodistribution and Systemic Clearance of Bacteriophages
Background and Objectives: Bacteriophages (phages) are viruses that selectively infect bacteria and are under renewed investigation as therapeutic agents against…
Read morePILOT STUDY AIMING TO QUANTIFY VIABLE BUT NON- OR SLOWLY REPLICATING MYCOBACTERIUM TUBERCULOSIS BACTERIA
Objectives Mycobacterium tuberculosis (Mtb) can exist in different metabolic states, ranging from fast-growing populations to viable but non- or slowly…
Read moreModel-informed pediatric drug development for clevidipine
Introduction: Clevidipine is an intravenous L‑type calcium channel blocker administered intravenously (IV) for the rapid reduction of blood pressure (BP)…
Read moreA REPEATED TIME-TO-EVENT ANALYSIS OF LENVATINIB-INDUCED DOSE-LIMITING TOXICITIES IN PATIENTS WITH DIFFERENTIATED THYROID CARCINOMA AND METASTATIC RENAL CELL CARCINOMA
Objectives: The multikinase inhibitor lenvatinib is poorly tolerated by differentiated thyroid cancer (DTC) and metastatic renal cell carcinoma (mRCC) patients…
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