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.
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 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…
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…
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.
Phase III Population Pharmacokinetics And Pharmacodynamics Of Azimilide
Azimilide (AZ) is a class III antiarrhythmic drug being developed for the treatment of symptomatic atrial fibrillation/flutter (AF/FL) and/or symptomatic paroxysmal supraventricular tachycardia…
The Development of a Population Pharmacokinetic (PK) Model for Linezolid
Linezoid (lzd) is an oxazolidinone antibiotic under development for infection due to gram-positive bacteria. It is rapidly and extensively absorbed following oral administration and initial PK studies…
Benchmarking And Risk Adjustment Of Patient Outcomes Across Anesthesia Provider Teams
In our current health care climate, it is becoming more common to compare patient outcome benchmarks across institutions and across providers within an institution. The JCAHO is mandating hospitals to…