In a fast-paced, pharmaceutical data analysis environment, the transfer of data needs to be quick and accurate. A number of steps are involved in coordinating data transfers. Data must be…
Pharmacokinetics-pharmacodynamics of cefepime and piperacillin-tazobactam against Escherichia coli and Klebsiella pneumoniae strains producing extended-spectrum beta-lactamases: report from the ARREST program
The frequency of resistance to beta-lactams among nosocomial isolates has been increasing due to extended-spectrum beta-lactamase (ESBL)-producing enteric bacilli.
Preparation and evaluation of ibuprofen beads by melt solidification technique
A novel single step melt solidification technique was developed for ibuprofen.
Comparison of Censored Regression (CR) vs Standard Regression (SR) Analyses for Modeling Relationships Between Minimum Inhibitory Concentrations (MIC) and Patient- and Institution-Specific Variables
A challenge in the treatment of resistant bacteria has been the difficulty in identifying patients likely to be infected with such pathogens. Novel methods may be applied to surveillance data to determine…
Application of Real-Time Data Assembly (RTDA) to a Pivotal Phase III Pediatric Trial: A Proactive Approach to Population Pharmacokinetic/Pharmacodynamic (PK/PD) Dataset Creation
To implement an RTDA process, similar to that described in the FDA Guidance for Industry: Population Pharmacokinetics, during a Phase III trial of linezolid (IV to oral) in pediatric patients which....
Pharmacokinetic/pharmacodynamic analysis of data from a phase III trial of linezolid IV/PO for the treatment of resistant gram-positive bacterial infections in children
Linezolid (LZD), the first approved oxazolidinone, is effective against Gram-positive infections. Population pharmacokinetic/dynamic (PK/PD) analyses of Phase III data were conducted to evaluate…
Asthma features in severe alpha1-antitrypsin deficiency: experience of the National Heart, Lung, and Blood Institute Registry
To describe asthma features in a cohort with alpha(1)-antitrypsin (AAT) deficiency, and determine the impact of asthma on FEV(1) decline.
Composite solubility versus pH profile and its role in intestinal absorption prediction
The purpose of this study was to examine absorption of basic drugs as a function of the composite solubility curve and intestinally relevant pH by using a gastrointestinal tract (GIT) absorption...
Microarray analysis of host cell gene transcription in response to varicella-zoster virus infection of human T cells and fibroblasts in vitro and SCIDhu skin xenografts in vivo
During primary infection, varicella-zoster virus (VZV) is spread via lymphocytes to skin, where it induces a rash and establishes latency in sensory ganglia.
Worldwide antimicrobial susceptibility patterns and pharmacodynamic comparisons of gatifloxacin and levofloxacin against Streptococcus pneumoniae: report from the antimicrobial resistance rate epidemiology study team
The use of fluoroquinolones for the treatment of community-acquired respiratory tract infection is increasing.
Temperature variability during preparation of Shouktik Bhasma and its consequences
Development of Bhasma involves complex unit operations including Shodhana, Marana and Bhavana, which need to be optimized to avoid batch-to-batch variations.
Current trends in the treatment of upper respiratory tract infections in neonates, infants and children: A survey
Scoparone produced a rapid and sustained fall of blood pressure in anaesthetized normotensive and experimental hypertensive animals and conscious normotensive rats.
Role of Aloe vera juice treatment (Bhavana) in preparation of Shouktik Bhasma
Preparation of Shouktik Bhasma (SB) involves intermittent trituration of heated material with Aloe vera juice.
Spherical Crystallization of Celecoxib
Celecoxib exhibits poor flow properties and compressibility.
Lack of Significant Drug Interactions for Sumanirole in Phase II Studies Using Population Pharmacokinetic (PPK) Methods
Sumanirole is a highly D2-selective dopamine receptor agonist that is in development for the treatment of Parkinson's disease (PD). Metabolism of sumanirole and in vitro data indicate that…
Evaluation of the Relationship Between Sumanirole Exposure and Orthostatic Hypotension
Sumanirole is a selective D2 receptor agonist in development for treatment of Parkinson's disease (PD). This agent is expected to have a better safety profile compared to other dopaminergic agents…
Evaluation of Covariate Effects on Population Pharmacokinetics (PPK) of Both Parent Drug and Metabolite(s) from Clinical Trial Data without Metabolite Administration or Excretion Sampling
To evaluate the influence of covariates on the PPK of both parent drug and metabolite(s) from clinical trial data with neither separate metabolite administration nor excretion sampling.
Pharmacokinetics/Pharmacodynamics in Otitis Media: Comparison of Time-Dependent Antibiotics in Middle Ear Fluid
An effective dosing regimen of b-lactam and macrolide antibiotics for otitis media involving S. pneumoniae (SP) requires that drug concentrations in middle ear fluid (MEF) remain above the MIC (T>MIC)…
Factors Influencing The Pharmacokinetics (Pk) Of The Anticancer Drug Irinotecan (Cpt-11) And Its Major Metabolites, Sn-38 And Sn-38g
To evaluate significant covariate effects on the PK of CPT-11 (C), SN-38 (S) and SN-38G (G).
Prediction of intestinal absorption: comparative assessment of GastroPlus and IDEA
We have assessed two commercial software tools employing physiologically based models for prediction of intestinal absorption in human.