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…
Clinical pharmacodynamics of quinolones
An understanding of fundamental PK-PD principles forms the basis for the rational use of antimicrobial agents. For quinolones, the fAUC24:MIC ratio is predictive of efficacy in animal and in vitro infection models, and in infected patients.
Gatifloxacin and the elderly: pharmacokinetic-pharmacodynamic rationale for a potential age-related dose reduction
Recently, anecdotal reports via the FDA's MedWatch reporting system have documented rare but serious hyperglycaemia in elderly patients receiving gatifloxacin.
Correlation between the physicochemical property of some nonsteroidal anti-inflammatory drugs and changes in adenosine triphosphate, glutathione and hemoglobin in rat erythrocytes
This study was conducted to explore the relationship between physicochemical property and toxic effectiveness using rat red blood cells (RBCs).
Preparation and characterization of ibuprofen–cetyl alcohol beads by melt solidification technique: effect of variables
Ibuprofen (IBU) exhibits short half-life, poor compressibility, flowability and caking tendency.
Relationships between patient and institution specific variables and decreased antimicrobial susceptibility of gram-negative pathogens
The identification of patients infected with antibiotic-resistant strains of bacteria for inclusion in clinical trials remains a serious challenge for the future development of agents for use against such infections.
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…
Pharmacokinetics-pharmacodynamics of cefepime and piperacillin-tazobactam against Escherichia coli and Klebsiella pneumoniae strains producing extended-spectrum beta-lactamases: report from the ARREST program
The frequency of resistance to beta-lactams among nosocomial isolates has been increasing due to extended-spectrum beta-lactamase (ESBL)-producing enteric bacilli.
Preparation and evaluation of ibuprofen beads by melt solidification technique
A novel single step melt solidification technique was developed for ibuprofen.
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....