Model Informed Drug Development Archives

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…

webdev2013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…

webdev2013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…

webdev2013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…

webdev2013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…

webdev2013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…

webdev2013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.…

webdev2013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…

webdev2013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,…

webdev2013年9月1日

Publication

Accounting for Transporters in Renal Clearance: Towards a Mechanistic Kidney Model (Mech KiM)

The impact of transporters in modulating the disposition of drugs in the liver and their…

webdev2013年8月20日

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モデルに基づく医薬品開発

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

Accounting for Transporters in Renal Clearance: Towards a Mechanistic Kidney Model (Mech KiM)

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