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.
Androgen receptor antagonists (antiandrogens): structure-activity relationships
Prostate cancer, acne, seborrhea, hirsutism, and androgenic alopecia are well recognized to depend upon an excess or increased sensitivity to androgens...
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…
Characterization of the highly variable bioavailability of tiludronate in normal volunteers using population pharmacokinetic methodologies
Currently, the use of classical bioequivalence criteria is being called into question for certain classes of drugs such as bisphosphonates. These compounds typically possess a wide therapeutic index but may...
Applying epidemiology-based outcomes research to clinical decision-making A hypothetical model of biotechnology therapy in gram-negative sepsis
Sepsis occurs in a heterogeneous population. A prospective nationwide surveillance study found that populations stratified by infection type had significant differences in the incidence...
Population pharmacokinetics of tirilazad: effects of weight, gender, concomitant phenytoin, and subarachnoid hemorrhage
Data collected during Phase I and II in the development of tirilazad were pooled and analyzed using nonlinear mixed effects models to assess covariates which might affect tirilazad pharmacokinetics.
Population pharmacokinetics of lamotrigine adjunctive therapy in adults with epilepsy
Plasma concentrations of lamotrigine, an antiepileptic drug obtained in three adult controlled clinical trials conducted in the United States were pooled
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…
Contributing Factors To Serious Adverse Outcomes
JCAHO is an accrediting body for hospitals in the United States. As part of the accreditation process, the JCAHO is initiating a new program called ORYX. The goal of the program is to integrate routinely…
An automated drug concentration screening and quality assurance program for clinical trials
The collection and analysis of drug concentration data collected during clinical trials is growing in popularity as a mechanism for explaining variability in patient outcomes.
Efficacy Of Bupropion Sr On Reducing Craving In Smoking Cessation
Bupropion HCl sustained release (Bup SR, ZybanTM) is the first non-nicotine treatment proven to be safe and effective for smoking cessation. Clinical studies have demonstrated that when used in…
Relationship between didanosine exposure and surrogate marker response in human immunodeficiency virus-infected outpatients
We used information available from routine clinic visits to characterize the pharmacokinetics of didanosine in 82 human immunodeficiency virus-infected patients.