Model Informed Drug Development Archives

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

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,…

Certara2013 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…

Certara2013 年 8 月 20 日

Publication

Temporal Profile of Lymphocyte Counts and Relationship with Infections with Fingolimod Therapy

Reduction in peripheral blood lymphocytes is an expected pharmacodynamic outcome of fingolimod therapy. The objective…

Certara2013 年 8 月 15 日

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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)

Temporal Profile of Lymphocyte Counts and Relationship with Infections with Fingolimod Therapy

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