To develop a population pharmacokinetic model describing the disposition of each enantiomer of antidepressant reboxetine and a pharmacodynamic model relating plasma concentrations and adverse effects.
A population pharmacokinetic-pharmacodynamic analysis and model validation of azimilide
Pharmacokinetic (PK) and pharmacodynamic (PD) models for azimilide were developed and validated with sparse blood sampling and QTc interval data obtained
Pharmacodynamics of fluoroquinolones against Streptococcus pneumoniae in patients with community-acquired respiratory tract infections
Fluoroquinolone antibiotic agents have demonstrated efficacy in the treatment of respiratory tract infections.
Implementation of a nursing home urinary incontinence management program with and without tolterodine
To evaluate the implementation of a nursing home urinary incontinence management program.
Predicting the impact of physiological and biochemical processes on oral drug bioavailability
Recent advances in computational methods applied to the fields of drug delivery and biopharmaceutics will be reviewed with a focus on prediction of the impact of physiological and biochemical factors on...
A New Paradigm in Pediatric Drug Development: The Application of Cognitive Engineering
Design of clinical trials in pediatrics is complicated by sensitive ethical considerations, a small pool of appropriate study subjects, and difficulty in determining drug dosing regimens. Cognitive engineering…
Transcend Global and Corporate Boundaries During Drug Development
We developed an innovative and alternative web-based strategy which combines a hypertext environment with human intelligence and creativity to lead a scientific audience through complex statistical…
Integrating Real-Time Data Assembly (RTDA) and Population Pharmacokinetics as Tactical Components of Cognitive Engineering
The goal of drug development is to produce a safe and efficacious drug that will thrive in a competitive marketplace. Cognitive engineering couples technology and human intelligence to generate and use…
Simulations Plus (“SLP”) Releases DDDPlus 4.0
One-of-a-Kind Product Gets Important New Capabilities
Ties in Proximity and Clustering Compounds
Hierarchical clustering algorithms such as Wards or complete-link are commonly used in compound selection and diversity analysis. Many such applications utilize binary representations of chemical structures...
Percolation Theory : Applications In Pharmacy
Percolation theory is a statistical theory applied to explain behaviour of disordered systems.
The Role of Population PK/PD Analysis During the Implementation of a Bridging Strategy for Linezolid
To describe the population PK/PD analysis process to support a bridging strategy for regulatory approval of Linezolid in Japan/Asia Pacific region.
Internet Based Communication Strategies to Support Linezolid Bridging Programs During Global Drug Development
To describe an Internet based communication strategy to facilitate scientific collaboration during the Linezolid global drug development program.
Integration of Pharmaceutical Product Development in Asia/Japan Into the Global Program
With increasing global acceptance of the provisions in various guideline documents resulting from the International Conferences on Harmonization (ICH) and the advent of regulatory changes in Asia Pacific…
Results of a new classification algorithm combining K nearest neighbors and recursive partitioning
We present results of a new computational learning algorithm combining favorable elements of two well-known techniques: K nearest neighbors and recursive partitioning.
Influence of Dose Size on Dose Response Relationships for Linezolid Efficacy Using Monte Carlo Simulations
Phase II linezolid (LZD) data analyses suggested that AUC0-24/MIC ratio was an important predictor of efficacy outcome. Monte Carlo simulations were performed to determine whether dose size…
Time Course Distributions of Laboratory Indices: A Strategy for Evaluating Laboratory Data from Clinical Trials
The traditional approach for assessing drug safety is to compute the baseline to end of treatment change in a laboratory measure. This strategy may miss important time-dependent value trends in patient...
Population Pharmacokinetics (PK) of Linezolid in Patients with Community-Acquired Pneumonia (CAP) and Skin and Soft Tissue (SST) Infections
A population PK analysis from 3 linezolid (LZD) trials was performed to estimate PK parameters in patients with CAP and SST infections, and evaluate patient covariate influence on LZD PK.
Characterization Of Oritavancin Pharmacokinetics (Pk) In Plasma And Blister Fluid In Normal Healthy Volunteers
Oritavancin is a novel glycopeptide antibiotic currently being developed for the treatment of complicated skin/skin structure infections (cSSSI), including those caused by multi-drug resistant Gram-positive…
A strategy for Urinary Incotinence Management in the Nursing Home – A Mandated Outcome Measure
Urinary incontinence (UI) is prevalent in more than 50% of nursing home residents. It significantly affects the quality of a resident's life and is one of the most common complaints by family members.