Model Informed Drug Development Archives

Publication

Predicted Heart Rate Effect of Inhaled LABA PF-00610355 in Volunteers and COPD Patients

The aim of this study was to assess the cardiovascular effects of a new inhaled…

Danielle Pillsbury2013 年 11 月 1 日

Publication

Prediction of Overall Survival or Progression Free Survival by Disease Control Rate at Week 8 Is Independent of Ethnicity: Western Versus Chinese Patients with First-line Non-small Cell Lung Cancer Treated with Chemotherapy with or without Bevacizumab

Categorizations of best response observed at week 8 of first-line treatment in two studies of…

Danielle Pillsbury2013 年 10 月 22 日

Publication

Inter-individual Variability in Levels of Human Microsomal Protein and Hepatocellularity per Gram of Liver

This study sought to determine levels of microsomal protein (MPPGL) and hepatocellularity (HPGL) per gram…

Danielle Pillsbury2013 年 10 月 1 日

Publication

Differential Pharmacokinetics of Ganitumab in Patients with Metastatic Pancreatic Cancer Versus Other Advanced Solid Cancers

Ganitumab is an investigational, fully human monoclonal antibody antagonist of the insulin-like growth factor-1 receptor…

Danielle Pillsbury2013 年 10 月 1 日

Publication

Exposure-response Analysis of Pertuzumab in HER2-positive Metastatic Breast Cancer: Absence of Effect on QTc Prolongation and Other ECG Parameters

The phase III trial of pertuzumab plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus…

Danielle Pillsbury2013 年 9 月 3 日

Publication

Toxicokinetics/Toxicodynamics of γ-hydroxybutyrate-ethanol Intoxication: Evaluation of Potential Treatment Strategies

γ-Hydroxybutyrate (GHB), a common drug of abuse, is often coingested with ethanol. Increasing renal clearance…

Danielle Pillsbury2013 年 9 月 1 日

Publication

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part I—Digoxin Pharmacokinetic Incorporating P-glycoprotein-mediated Efflux

A prerequisite for the prediction of the magnitude of P-glycoprotein (P-gp)-mediated drug-drug interactions between digoxin…

Danielle Pillsbury2013 年 9 月 1 日

Publication

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin

Digoxin is the recommended substrate for assessment of P-glycoprotein (P-gp)-mediated drug-drug interactions (DDIs) in vivo.…

Danielle Pillsbury2013 年 9 月 1 日

Publication

Using Historical Control Information for the Design and Analysis of Clinical Trials with Overdispersed Count Data

Results from clinical trials are never interpreted in isolation. Previous studies in a similar setting…

Danielle Pillsbury2013 年 9 月 1 日

Publication

Siponimod for Patients with Relapsing-remitting Multiple Sclerosis (BOLD): An Adaptive, Dose-ranging, Randomized, Phase 2 Study

Siponimod is an oral selective modulator of sphingosine 1-phosphate receptor types 1 and type 5,…

Danielle Pillsbury2013 年 9 月 1 日

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Predicted Heart Rate Effect of Inhaled LABA PF-00610355 in Volunteers and COPD Patients

Prediction of Overall Survival or Progression Free Survival by Disease Control Rate at Week 8 Is Independent of Ethnicity: Western Versus Chinese Patients with First-line Non-small Cell Lung Cancer Treated with Chemotherapy with or without Bevacizumab

Inter-individual Variability in Levels of Human Microsomal Protein and Hepatocellularity per Gram of Liver

Differential Pharmacokinetics of Ganitumab in Patients with Metastatic Pancreatic Cancer Versus Other Advanced Solid Cancers

Exposure-response Analysis of Pertuzumab in HER2-positive Metastatic Breast Cancer: Absence of Effect on QTc Prolongation and Other ECG Parameters

Toxicokinetics/Toxicodynamics of γ-hydroxybutyrate-ethanol Intoxication: Evaluation of Potential Treatment Strategies

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part I—Digoxin Pharmacokinetic Incorporating P-glycoprotein-mediated Efflux

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin

Using Historical Control Information for the Design and Analysis of Clinical Trials with Overdispersed Count Data

Siponimod for Patients with Relapsing-remitting Multiple Sclerosis (BOLD): An Adaptive, Dose-ranging, Randomized, Phase 2 Study

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