AP23573 is a novel non-prodrug rapamycin analog that potently inhibits mTOR (through bivalent binding to FKBP and mTOR), a downstream effector of PI3K/Akt and nutrient-sensing pathways. A PK model was…
Pharmacodynamic Characterization of NVP-LMB415 against Haemophilus Influenzae in an In Vitro Hollow-Fiber System
NVP-LBM415 is a peptide deformylase inhibitor with in vitro activity against those pathogens commonly associated with community-acquired respiratory tract infections. The purpose of these studies was to…
Exposure-Response Analysis Of The Efficacy Of Tigecycline In Patients With Complicated Skin And Skin-Structure Infections
Tigecycline, the first glycylcycline to reach clinical trials, is in development for the treatment of patients with serious infections, including complicated skin and skin-structure infections (cSSSI).
Pharmacokinetic/Pharmacodynamic Model For The Tolerability Of Tigecycline In Healthy Volunteers
Tigecycline, a first-in-class glycylcycline, is an antimicrobial agent with demonstrated in vitro activity against susceptible and multiple-drug resistant gram-positive and gram-negative bacteria.
A Novel Approach For Evaluating The Microbiological Efficacy Of Tigecycline In Patients With Complicated Skin And Skin-Structure Infections
Tigecycline is a glycylcycline in development for the treatment of patients with serious infections, including complicated skin and skin-structure infections (cSSSI). While cSSSI can be caused by a…
Effect of Hepatic Impairment on the Pharmacokinetics of the Novel Glycopeptide Oritavancin
Oritavancin (ORI) is a semisynthetic glycopeptide being developed for the treatment of serious gram-positive infections. Physiochemical properties of ORI lead to extensive tissue distribution, with uptake…
Evaluation of the Bias and Precision of Bayesian Parameter Estimates When Applying a Phase I Model to Sparse Patient Data
A simulation study was conducted to assess the use of a Phase 1 population PK model to estimate Bayesian parameters in Phase 2/3 patients. Specifically, the bias and precision of the Bayesian parameter…
Monte Carlo Simulation To Estimate In Vitro Susceptibility Breakpoints For Moxifloxacin, Gatifloxacin, And Levofloxacin Against Staphylococcus Aureus
Emerging resistance with staphylococci has called for a change in treatment paradigms and review of breakpoints. Current NCCLS breakpoints for gatifloxacin and levofloxacin against Staphylococcus spp...
Population Pharmacokinetics of Doripenem
Doripenem is a broad-spectrum carbapenem currently in development for treatment of bacterial infections. Previously, we presented a population pharmacokinetic (PK) model for doripenem in…
Population Pharmacokinetics of Tigecycline in Phase 1 Subjects
TGC is the first glycylcycline antimicrobial agent in development and has potent in vitro activity against many multi-drug resistant organisms. Given observed differences in the PK profiles after single...
Postoperative Infection Rate Following Cardiac Surgery With Allogeneic vs Other Blood Management Techniques
Infection rates associated with allogeneic blood transfusion versus other blood management techniques were prospectively compared in elective cardiac surgery patients (anticipated blood loss > 1000 mL).
Blood Management and Infections in Cardiovascular and Orthopedic Surgery
Numerous risks are associated with allogeneic blood transfusions. Various blood management techniques have evolved which minimize or eliminate the use of allogeneic blood. This study compared infection rates…
Use of an in vitro Pharmacodynamic Model & Monte Carlo Simulation to Characterize the Pharmacokinetics and Pharmacodynamics of Gatifloxacin vs Salmonella Typhi
Salmonella enterica serotype Typhi and non-typohoidal Salmonella remain major causes of morbidity and mortality worldwide. Ampicillin, trimethoprim-sulfamethoxazole, and chloramphenicol no longer…
Pharmacokinetics (PK) of Tigecycline (TG) in Healthy Adult Volunteers and in Subjects with Renal Impairment
TG is a novel glycylcycline antibiotic with an expanded spectrum of activity, which includes gram-positive, gram-negative, atypical, and anaerobic pathogens. TG has also shown activity against pathogens…
The Impact of Mivacurium and Rocuronium on Recovery Times in Ambulatory Anesthesia Procedures
This study w as designed to evaluate the recovery times of patients undergoing ambulatory surgery w ith the short-acting, fastemergence anesthetic muscle relaxants, mivacurium, and rocuronium.
A Novel Pharmacodynamic Model for Gatifloxacin vs. Salmonella typhi in Timed Kill Curves
Quinolones are the mainstay of treatment for Salmonella typhi (S. typhi) infections but there is growing concern about resistance to older quinolones & poor understanding of quinolone /S. typhi…
Pharmacokinetic Analysis of Gatifloxacin in Plasma and Sinus Aspirate During Treatment of Acute Maxillary Sinusitis
A novel approach to collect sinus exudate was utilized and the time course of gatifloxacin (GAT) in the blood and at the primary infection site were assessed during treatment for acute maxillary sinusitis (AMS).
Comparison of Parametric (NONMEM®) and Non-Parametric (NPEM®) Methods for Population Pharmcokinetic Modeling of Bi-Model Populations
Debate exists whether the most appropriate population analysis method is parametric (NONMEM®) or non-parametric (NPEM®), especially for data from a bi-modal population (i.e., poor/extensive metabolizers...
PK-PD Evaluation of Doripenem (DOR) Against Extended Spectrum ß-Lactamase (ESBL) Producing Enterobacteraceae
Increasing resistance among ESBL-producing bacteria is a growing concern. We examined the potential utility of DORI against ESBL-producing isolates.
Gatifloxacin Exposure in Maxillary Sinus and Middle Ear – All Sites of Infection Are Not Created Equal
Due to the similar physiology of maxillary sinus (MS) and middle ear (ME), it is often assumed that antimicrobial penetration is similar into MS and ME fluids. Traditional methods for assessing drug penetration…