Pharmaceutical systems containing a mixture of drug, excipients, and polymer can be used as effective controlled release formulations. The presence of drug and excipients in the polymer matrix creates a…
Population Pharmacokinetics of Tigecycline in Patients with Complicated Skin and Skin-Structure and Intra-Abdominal Infections
Tigecycline is a novel glycylcycline antibiotic with expanded broad-spectrum in vitro activity, including emerging multidrug-resistant pathogens. The goal of this analysis was to develop a PPK model for…
Noncompartmental Pharmacokinetics of Tigecycline in Phase 3 Studies of Patients with Complicated Skin and Skin-Structure and Intra-Abdominal Infections
Tigecycline is the first glycylcycline to reach Phase 3 clinical trials and is active against multidrug-resistant organisms. Four Phase 3 studies have examined tigecycline for the treatment of complicated…
Adult and Pediatric GastroPlus-PBPK Simulations of Gabapentin using in silico Population Estimates for Age-Related (PEAR) Physiology
To evaluate the accuracy of prediction of Midazolam absorption and bioavailability in a pediatric population from in silico, in vitro and adult in vivo data. The significance of scaling of the clearance and…
Population Pharmacokinetics of Tigecycline in Patients with Complicated Intra-abdominal or Skin and Skin-Structure Infections
Tigecycline is a novel glycylcycline antibiotic demonstrating broad-spectrum in vitro activity. A previously developed population pharmacokinetic (PK) model was utilized to generate individual predicted…
Population Pharmacokinetics of Modafinil Film-Coated Tablets in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
Modafinil is currently being evaluated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. A population pharmacokinetic model was developed…
Pharmacokinetic/Pharmacodynamic Model for the Safety of Tigecycline in Patients with Complicated Skin and Skin-Structure Infections
Tigecycline is a first-in-class glycylcycline for the treatment of serious bacterial infections. Reported adverse events from clinical trials include nausea and vomiting. Exposure-response relationships and…
Development Of A Pharmacokinetic (Pk) Model And Assessment Of Patient (Pt) Covariate Effects On Dose-Dependent Pk Following Different Dosing Schedules In Two Phase I Trials Of Ap23573 (Ap), An Mtor Inhibitor
AP23573 is a novel non-prodrug rapamycin analog that potently inhibits mTOR (through bivalent binding to FKBP and mTOR), a downstream effector of PI3K/Akt and nutrient-sensing pathways. A PK model was…
Pharmacodynamic Characterization of NVP-LMB415 against Haemophilus Influenzae in an In Vitro Hollow-Fiber System
NVP-LBM415 is a peptide deformylase inhibitor with in vitro activity against those pathogens commonly associated with community-acquired respiratory tract infections. The purpose of these studies was to…
Exposure-Response Analysis Of The Efficacy Of Tigecycline In Patients With Complicated Skin And Skin-Structure Infections
Tigecycline, the first glycylcycline to reach clinical trials, is in development for the treatment of patients with serious infections, including complicated skin and skin-structure infections (cSSSI).
Pharmacokinetic/Pharmacodynamic Model For The Tolerability Of Tigecycline In Healthy Volunteers
Tigecycline, a first-in-class glycylcycline, is an antimicrobial agent with demonstrated in vitro activity against susceptible and multiple-drug resistant gram-positive and gram-negative bacteria.
A Novel Approach For Evaluating The Microbiological Efficacy Of Tigecycline In Patients With Complicated Skin And Skin-Structure Infections
Tigecycline is a glycylcycline in development for the treatment of patients with serious infections, including complicated skin and skin-structure infections (cSSSI). While cSSSI can be caused by a…
Effect of Hepatic Impairment on the Pharmacokinetics of the Novel Glycopeptide Oritavancin
Oritavancin (ORI) is a semisynthetic glycopeptide being developed for the treatment of serious gram-positive infections. Physiochemical properties of ORI lead to extensive tissue distribution, with uptake…
Evaluation of the Bias and Precision of Bayesian Parameter Estimates When Applying a Phase I Model to Sparse Patient Data
A simulation study was conducted to assess the use of a Phase 1 population PK model to estimate Bayesian parameters in Phase 2/3 patients. Specifically, the bias and precision of the Bayesian parameter…
Monte Carlo Simulation To Estimate In Vitro Susceptibility Breakpoints For Moxifloxacin, Gatifloxacin, And Levofloxacin Against Staphylococcus Aureus
Emerging resistance with staphylococci has called for a change in treatment paradigms and review of breakpoints. Current NCCLS breakpoints for gatifloxacin and levofloxacin against Staphylococcus spp...
Population Pharmacokinetics of Doripenem
Doripenem is a broad-spectrum carbapenem currently in development for treatment of bacterial infections. Previously, we presented a population pharmacokinetic (PK) model for doripenem in…
Population Pharmacokinetics of Tigecycline in Phase 1 Subjects
TGC is the first glycylcycline antimicrobial agent in development and has potent in vitro activity against many multi-drug resistant organisms. Given observed differences in the PK profiles after single...
Postoperative Infection Rate Following Cardiac Surgery With Allogeneic vs Other Blood Management Techniques
Infection rates associated with allogeneic blood transfusion versus other blood management techniques were prospectively compared in elective cardiac surgery patients (anticipated blood loss > 1000 mL).
Blood Management and Infections in Cardiovascular and Orthopedic Surgery
Numerous risks are associated with allogeneic blood transfusions. Various blood management techniques have evolved which minimize or eliminate the use of allogeneic blood. This study compared infection rates…
Use of an in vitro Pharmacodynamic Model & Monte Carlo Simulation to Characterize the Pharmacokinetics and Pharmacodynamics of Gatifloxacin vs Salmonella Typhi
Salmonella enterica serotype Typhi and non-typohoidal Salmonella remain major causes of morbidity and mortality worldwide. Ampicillin, trimethoprim-sulfamethoxazole, and chloramphenicol no longer…