Relationships between patient and institution specific variables and decreased antimicrobial susceptibility of gram-negative pathogens

Relationships between patient and institution specific variables and decreased antimicrobial susceptibility of gram-negative pathogens

Publication: Clin Infect Dis
Division: Cognigen

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 Enterobacter spp. and Hospital – and Patient – Specific Variables: Report from the Antimicrobial Resistance Rate Epidemiology Study Team (ARREST Program)

Relationships Between Susceptibility of Enterobacter spp. and Hospital – and Patient – Specific Variables: Report from the Antimicrobial Resistance Rate Epidemiology Study Team (ARREST Program)

Conference: ECCMID
Division: Cognigen

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

You’ve Got Data! Using SAS from Data Receipt to Reporting

Authors: Vecchione P
Conference: Pharmaceutical Industry SAS Users Group (PharmaSUG)
Division: Cognigen

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

Comparison of Censored Regression (CR) vs Standard Regression (SR) Analyses for Modeling Relationships Between Minimum Inhibitory Concentrations (MIC) and Patient- and Institution-Specific Variables

Conference: ASCPT
Division: Cognigen

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

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

Conference: ASCPT
Division: Cognigen

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

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

Conference: ASCPT
Division: Cognigen

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…

Composite solubility versus pH profile and its role in intestinal absorption prediction

Composite solubility versus pH profile and its role in intestinal absorption prediction

Publication: AAPS PharmSci
Software: GastroPlus®
Division: Simulations Plus

The purpose of this study was to examine absorption of basic drugs as a function of the composite solubility curve and intestinally relevant pH by using a gastrointestinal tract (GIT) absorption...

Microarray analysis of host cell gene transcription in response to varicella-zoster virus infection of human T cells and fibroblasts in vitro and SCIDhu skin xenografts in vivo

Microarray analysis of host cell gene transcription in response to varicella-zoster virus infection of human T cells and fibroblasts in vitro and SCIDhu skin xenografts in vivo

Authors: Jones JO, Arvin AM
Publication: J Virol
Division: Simulations Plus

During primary infection, varicella-zoster virus (VZV) is spread via lymphocytes to skin, where it induces a rash and establishes latency in sensory ganglia.

Lack of Significant Drug Interactions for Sumanirole in Phase II Studies Using Population Pharmacokinetic (PPK) Methods

Lack of Significant Drug Interactions for Sumanirole in Phase II Studies Using Population Pharmacokinetic (PPK) Methods

Conference: AAPS
Division: Cognigen

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…