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…
Data Analysis of High-Throughput Screening Results: Application of Multidomain Clustering to the NCI Anti-HIV Data Set
The routine use of high-throughput screening (HTS) systems in the drug discovery process has resulted in an increasing need for fast, reliable analysis of massive amounts of data.
Rapid Assessment of Data Set Structures
When SAS® data is received from an external source, such as a sponsor, CRO, or another department, it is important to assess the new data to determine if variables have been added or removed, locate…
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).
Uniqueness of Solutions to Compartmental Models of Population Pharmacokinetics for Drugs Undergoing Complex Metabolism
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…