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.
Pharmacokinetics/Pharmacodynamics in Otitis Media: Comparison of Time-Dependent Antibiotics in Middle Ear Fluid
An effective dosing regimen of b-lactam and macrolide antibiotics for otitis media involving S. pneumoniae (SP) requires that drug concentrations in middle ear fluid (MEF) remain above the MIC (T>MIC)…
Factors Influencing The Pharmacokinetics (Pk) Of The Anticancer Drug Irinotecan (Cpt-11) And Its Major Metabolites, Sn-38 And Sn-38g
To evaluate significant covariate effects on the PK of CPT-11 (C), SN-38 (S) and SN-38G (G).
Population Pharmacokinetics (PK) Of Linezolid In Neonates And Young Infants
Linezolid (LZD) is the first approved oxazolidinone antibiotic and has shown broad activity against gram-positive bacteria, including VRE and MRSA. Previous studies indicated LZD clearance was higher in…
Population Pharmacodynamic Assessment of Atazanavir Exposure, Uridine Diphosphate-Glucuronosyl Transferase (UGT) 1A1 Genotype and Safety in Healthy Subjects
Atazanavir (BMS-232632) is a potent HIV-protease inhibitor with a favorable resistance profile in vitro. Dose-related elevations of total bilirubin (primarily unconjugated) have been observed with…
A New Paradigm of Real-Time Data Assembly to Support Knowledge-Based Decision Making: A Case Study
Real-time data assembly (RTDA) to support knowledgebased decision making was implemented for the development of a compound during Phase II. Program goals were to develop a data warehouse to expedite…
Comparison of Post-Operative Nosocomial Infection Associated with Blood Management Techniques in Cardiovascular and Orthopedic Surgery
Numerous risks are associated with allogeneic blood transfusions, however non-allogeneic blood options can minimize the use of allogeneic blood. This study compared infection rates associated with blood…
Simultaneous Population Pharmacokinetic (PBK) Modeling of Irinotecan (CPT-11) and its Major Metabolites, SN 38 and SN-38G
To develop a PPK model in NONMEM® that simultaneously predicts the plasma concentration (Cp) profiles of CPT-11 (C) and its metabolites, SN-38 (S) and SN-38G (G).