To develop a population pharmacokinetic (PPK) model for paliperidone extended-release (ER) and to evaluate the influence of selected covariates.
Population Pharmacokinetics of (R)-Albuterol Following Inhaled Levalbuterol or Racemic Albuterol via a Hydrofluoroalkane Metered Dose Inhaler in Pediatric and Adult Asthma Patients
Levalbuterol (LEV), the (R)-enantiomer of racemic albuterol (RA), is approved for the treatment or prevention of bronchospasm in patients ≥4 years of age via metered dose inhaler (MDI). A population…
Population Pharmacokinetics of Nebulized Arformoterol in Subjects with COPD
(R,R)-Formoterol (ARF) is a highly selective, potent and long-acting β2-adrenoceptor agonist currently under development in the US for the longterm maintenance treatment of bronchoconstriction associated…
Exposure-Response Relationship for Nebulized Arformoterol in Subjects with COPD
Arformoterol (ARF) is a highly selective, potent, long-acting β2-adrenoceptor agonist under development in the US for the maintenance treatment of bronchoconstriction associated with COPD. An initial…
Pharmacokinetic/Pharmacodynamic (PK/PD) Model for the Safety of Tigecycline (T) in Patients with Complicated Intra-Abdominal Infections (cIAI)
Nausea (N) and vomiting (V) have been reported with tigecycline, a new glycylcycline with expanded broad spectrum activity. 140 exposure-response relationships and patient covariates predictive of the first N…
Pharmacokinetic/pharmacodynamic (PK/PD) Model for Tolvaptan in Healthy Subjects
Direct effect, indirect effect, and competitive antagonism models were evaluated to describe plasma tolvaptan concentration effect on urine flow rate (UFR), with consideration of water intake rate (WIR)…
Simulation of Midazolam Absorption and Bioavailability in Pediatric Patients
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…
In Vitro Simulation Adinazolam Mesylate Swellable HPMC Matrix Release Using DDDPlus™ Software
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…