To develop an integrated model for drug absorption from the oral cavity. The model simulates combined absorption of a drug from both the oral cavity and the gastrointestinal tract.
Simulation of Gabapentin Absorption and Bioavailability in Pediatric Patients
To fit an absorption-pharmacokinetic model for simulation of Gabapentin in adult and pediatric populations. The model will be able to describe the nonlinear dose dependence of absorption mediated by an amino…
Population Pharmacokinetics of Bendamustine and Metabolites in Patients With Indolent Non-Hodgkin Lymphoma
Bendamustine is a bifunctional alkylating agent in development as monotherapy and in combination with other agents in the treatment of indolent non-Hodgkin lymphoma (NHL).
Model Feasibility Assessment as a Driver for Model-Based Drug Development
Complex pharmacometric analyses raise concerns about cost, time, and reliability of the modelbuilding process (MBP). The goal was to use a model feasibility assessment (MFA) process to improve the performance…
PK/PD Modeling of Adinazolam
Develop a model for prediction of the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of Adinazolam from IV, immediate release oral, and controlled release oral formulations.
Influence Of Estimation Of Inter-Occasion Variability On Detection Of Time-Varying Covariates
To explore the influence of the estimation of inter-occasion variability (IOV) on the ability to detect time-varying covariates influencing PK parameters from a population PK (PPK) analysis using NONMEM.
Plasma Pharmacokinetic (PK) Profile of Two Consecutive Doses of Ferumoxytol in Healthy Subjects
Ferumoxytol is a carbohydrate-coated superparamagnetic iron oxide nanoparticle being evaluated for safety and efficacy in two distinct areas of medical need.
Effect of Formulation on Adinazolam Pharmacokinetics and Pharmacodynamics
Adinazolam has been reported to have anxiolytic and antidepressant properties [1]. Numerous pharmacokinetic (PK) and pharmacodynamic (PD) studies of immediate release as well as sustained release…
Designing In Vitro Dissolution Tests to Better Mimic In Vivo Release
In vitro dissolution tests were traditionally designed for quality control. USP methods commonly used to evaluate the release rate of new controlled release dosage forms are often based on such experiments.
The Application of Systematic Analysis for Identifying and Addressing the Needs of the Pharmacometric Process
The current implementation of a pharmacometric process has, in most cases, grown from the ad hoc application of modeling and simulation activities to the drug-development process. This ad hoc…
Mechanism-Based Pharmacokinetic / Pharmacodynamic Model for Hepatoprotective Effect of Dexamethasone on Transient Transaminitis After Trabectedin (ET-743, Yondelis®) Treatment
Reversible transient elevations in transaminases have been observed after trabectedin (T) administration, despite no alteration in plasma PK. A PKPD model was developed to evaluate the time course of ALT elevation…
Effect of Lifestyle Intervention on the Placebo Response in Anti-Obesity Trials: Considerations for Exposure-Response Modeling
Successful clinical development of anti-obesity agents is aided by characterization of the placebo effect, which can be significant when lifestyle intervention (LSI) accompanies pharmacologic therapy.
Model-Based Evaluations to Select and Confirm Doses in the Clinical Development of Exenatide
Population pharmacokinetic (PK) and pharmacodynamic (PK/PD) models based on early Phases 1 and 2 data for the new antidiabetic medication exenatide (ex) supported transition from weight-based to…
Population Pharmacokinetics of Paliperidone ER in Healthy Subjects and Patients With Schizophrenia
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…