To investigate parameter identifiability and uniqueness of solutions to compartmental population pharmacokinetic (PPK) models for drugs with complex metabolism.
Comparison of Laboratory Safety Data from Japanese and Non-Japanese in Linezolid Phase I Studies
The laboratory safety data of linezolid (lzd) pooled from 6 multi-dose Phase I studies were compared in 65 Japanese (J) and 56 non-Japanese (non-J) subjects.
Comparison of Linezolid Pharmacokinetics from Phase I Studies of Japanese and Caucasians
This bridging analysis compared pharmacokinetic (PK) parameters for linezolid (lzd) observed in Japanese (J) and Caucasians (C) in traditional PK Phase I studies.
Population Modeling to Guide Phase 3 Dose Selection for AC2993 (Synthetic Exendin-4)
AC2993 is a novel glucose lowering agent for the treatment of patients with type 2 diabetes.
Pharmacodynamic considerations in the treatment of moderate to severe pseudomonal infections with cefepime
Pseudomonas aeruginosa is one of the more common and clinically difficult-to-treat causes of hospital-acquired infections.
Pharmacodynamics in the evaluation of drug regimens
We believe, especially in an era of increasing antimicrobial resistance, that the integration of PK/PD models and stochastic techniques provides a powerful new tool...
Pharmacodynamic profiling of levofloxacin and gatifloxacin using Monte Carlo simulation for community-acquired isolates of Streptococcus pneumoniae
In vitro and in vivo models of infection suggest that the area under the concentration-time curve (AUC): minimum inhibitory concentration (MIC) ratio...
Population Pharmacodynamic (PD) Assessment of the Safety and Antiretroviral Activity of Atazanavir (BMS-232632)
Atazanavir (BMS-232632), currently in Phase III development, is a well-tolerated, once-daily protease inhibitor (PI) which does not appear to elevate cholesterol or triglyceride blood levels and has…
Population Pharmacokinetics/Pharmacodynamics of Antidepressant R,R(-) and S,S(+) Reboxetine (RBX)
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.