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…
Serial Sinus Aspirate Sampling (SSAS): A Novel Technique for Evaluating Antimicrobial Therapy of Acute Maxillary Sinusitis (AMS)
The relationship between drug exposure and the time course of antimicrobial effect at the primary infection site for acute maxillary sinusitis has not previously been explored. Purpose. To quantify the time…
PK-PD Target Attainment with Monte Carlo Simulation as Decision Support of Phase 2 / 3 Dosing Strategies for the Clinical Development of Doripenem
Integration of Phase 1 pharmacokinetic (PK) and non-clinical data provides for the potential to optimize antimicrobial dosing regimens for Phase 2/3 studies. A murine-thigh infection model identified the…
Relationship Between Increased Levofloxacin Use and Decreased Susceptibility of Streptococcus pneumoniae: Report From the ARREST Program
Increasing reports describing the emergence of quinolone nonsusceptible Streptococcus pneumoniae (SP) are of clinical concern. We examined the relationship between outpatient quinolone use and susceptibility…
Relationships Between Susceptibility of Streptococcus pneumoniae and Hospital- and Patient-Specific Variables: Report from the Antimicrobial Resistance Rate Epidemiology Study Team (ARREST Program)
S. pneumoniae remains a leading cause of morbidity and mortality worldwide. The ARREST Program was established as a multidisciplinary, collaborative effort to use surveillance data and analytic techniques to…
Relationships Between Susceptibility of Pseudomonas aeruginosa and Hospital- and Patient-Specific Variables: Report from the Antimicrobial Resistance Rate Epidemiology Study Team (ARREST Program)
Identification of patients with infection associated with antibiotic-resistant pathogens remains a serious challenge for the study of drug regimens to treat such infections. The ARREST Program was…
Relationships Between Susceptibility of Enterobacter spp. and Hospital – and Patient – Specific Variables: Report from the Antimicrobial Resistance Rate Epidemiology Study Team (ARREST Program)
Identification of patients with infection associated with antibioticresistant pathogens remains a serious challenge for the study of drug regimens to treat such infections. The ARREST Program was established…
You’ve Got Data! Using SAS from Data Receipt to Reporting
In a fast-paced, pharmaceutical data analysis environment, the transfer of data needs to be quick and accurate. A number of steps are involved in coordinating data transfers. Data must be…
Comparison of Censored Regression (CR) vs Standard Regression (SR) Analyses for Modeling Relationships Between Minimum Inhibitory Concentrations (MIC) and Patient- and Institution-Specific Variables
A challenge in the treatment of resistant bacteria has been the difficulty in identifying patients likely to be infected with such pathogens. Novel methods may be applied to surveillance data to determine…
Application of Real-Time Data Assembly (RTDA) to a Pivotal Phase III Pediatric Trial: A Proactive Approach to Population Pharmacokinetic/Pharmacodynamic (PK/PD) Dataset Creation
To implement an RTDA process, similar to that described in the FDA Guidance for Industry: Population Pharmacokinetics, during a Phase III trial of linezolid (IV to oral) in pediatric patients which....
Pharmacokinetic/pharmacodynamic analysis of data from a phase III trial of linezolid IV/PO for the treatment of resistant gram-positive bacterial infections in children
Linezolid (LZD), the first approved oxazolidinone, is effective against Gram-positive infections. Population pharmacokinetic/dynamic (PK/PD) analyses of Phase III data were conducted to evaluate…
Lack of Significant Drug Interactions for Sumanirole in Phase II Studies Using Population Pharmacokinetic (PPK) Methods
Sumanirole is a highly D2-selective dopamine receptor agonist that is in development for the treatment of Parkinson's disease (PD). Metabolism of sumanirole and in vitro data indicate that…
Evaluation of the Relationship Between Sumanirole Exposure and Orthostatic Hypotension
Sumanirole is a selective D2 receptor agonist in development for treatment of Parkinson's disease (PD). This agent is expected to have a better safety profile compared to other dopaminergic agents…
Evaluation of Covariate Effects on Population Pharmacokinetics (PPK) of Both Parent Drug and Metabolite(s) from Clinical Trial Data without Metabolite Administration or Excretion Sampling
To evaluate the influence of covariates on the PPK of both parent drug and metabolite(s) from clinical trial data with neither separate metabolite administration nor excretion sampling.