Model Informed Drug Development Archives

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Introduction to Population PK/PD Analysis Using Phoenix NLME

Phoenix NLME provides sophisticated algorithms and powerful and flexible data processing and modeling tools for…

Certara2013年11月14日

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…

Certara2013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…

Certara2013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…

Certara2013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…

Certara2013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…

Certara2013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…

Certara2013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…

Certara2013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.…

Certara2013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…

Certara2013年9月1日

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モデルに基づく医薬品開発

Introduction to Population PK/PD Analysis Using Phoenix NLME

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

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