Model Informed Drug Development Archives

Publication

The Effect of Plasmapheresis on Blood Pressure in Voluntary Plasma Donors

Donor plasmapheresis involves the removal of a weight-adjusted volume of plasma and the return of…

Danielle Pillsbury2015 年 1 月 1 日

Publication

Population Dose-response Analysis of Daily Seizure Count Following Vigabatrin Therapy in Adult and Pediatric Patients with Refractory Complex Partial Seizures

Vigabatrin is an irreversible inhibitor of γ-aminobutyric acid transaminase (GABA-T) and is used as an…

Danielle Pillsbury2015 年 1 月 1 日

Publication

Pharmacokinetics of Injectable, Long-acting Nevirapine for HIV Prophylaxis in Breastfeeding Infants

Mother-to-child transmission (MTCT) of HIV-1 remains a global health problem. The World Health Organization (WHO…

Danielle Pillsbury2015 年 1 月 1 日

Publication

Onartuzumab with or without Bevacizumab in Combination with Weekly Paclitaxel Does Not Prolong QTc or Adversely Affect Other ECG Parameters in Patients with Locally Recurrent or Metastatic Triple-negative Breast Cancer

The purpose of this study was to examine the potential effect of onartuzumab, when administered…

Danielle Pillsbury2014 年 12 月 17 日

Publication

Meropenem in Children Receiving Continuous Renal Replacement Therapy: Clinical Trial Simulations Using Realistic Covariates

Meropenem is frequently prescribed in children receiving continuous renal replacement therapy (CRRT). Fluid overload is…

Danielle Pillsbury2014 年 12 月 1 日

Publication

Vigabatrin Pediatric Dosing Information for Refractory Complex Partial Seizures: Results from a Population Dose-response Analysis

We predicted vigabatrin dosages for adjunctive therapy for pediatric patients with refractory complex partial seizures…

Danielle Pillsbury2014 年 12 月 1 日

Publication

Modeling and Simulation for Medical Product Development and Evaluation: Highlights from the FDA-C-Path-ISOP 2013 Workshop

Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration…

Danielle Pillsbury2014 年 12 月 1 日

Publication

Applications of Linking PBPK and PD Models to Predict the Impact of Genotypic Variability, Formulation Differences, Differences in Target Binding Capacity and Target Site Drug Concentrations on Drug Responses and Variability

This study aimed to demonstrate the added value of integrating prior in vitro data and…

Danielle Pillsbury2014 年 11 月 26 日

Publication

Population Pharmacokinetics Analysis of Vigabatrin in Adults and Children with Epilepsy and Children with Infantile Spasms

Vigabatrin is an inhibitor of γ-aminobutyric acid transaminase. The purpose of these analyses was to…

Danielle Pillsbury2014 年 11 月 1 日

Publication

The Rise of Systems Pharmacology in Drug Discovery and Development

Danielle Pillsbury2014 年 10 月 1 日

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The Effect of Plasmapheresis on Blood Pressure in Voluntary Plasma Donors

Population Dose-response Analysis of Daily Seizure Count Following Vigabatrin Therapy in Adult and Pediatric Patients with Refractory Complex Partial Seizures

Pharmacokinetics of Injectable, Long-acting Nevirapine for HIV Prophylaxis in Breastfeeding Infants

Onartuzumab with or without Bevacizumab in Combination with Weekly Paclitaxel Does Not Prolong QTc or Adversely Affect Other ECG Parameters in Patients with Locally Recurrent or Metastatic Triple-negative Breast Cancer

Meropenem in Children Receiving Continuous Renal Replacement Therapy: Clinical Trial Simulations Using Realistic Covariates

Vigabatrin Pediatric Dosing Information for Refractory Complex Partial Seizures: Results from a Population Dose-response Analysis

Modeling and Simulation for Medical Product Development and Evaluation: Highlights from the FDA-C-Path-ISOP 2013 Workshop

Applications of Linking PBPK and PD Models to Predict the Impact of Genotypic Variability, Formulation Differences, Differences in Target Binding Capacity and Target Site Drug Concentrations on Drug Responses and Variability

Population Pharmacokinetics Analysis of Vigabatrin in Adults and Children with Epilepsy and Children with Infantile Spasms

The Rise of Systems Pharmacology in Drug Discovery and Development

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