Model Informed Drug Development Archives

Publication

Population Pharmacokinetic-pharmacodynamic-disease Progression Model for Effects of Anakinra in Lewis Rats with Collagen-induced Arthritis

A population pharmacokinetic-pharmacodynamic-disease progression (PK/PD/DIS) model was developed to characterize the effects of anakinra in…

CertaraDecember 1, 2011

Publication

Model-based Meta-analysis for Comparative Efficacy and Safety: Application in Drug Development and Beyond

High development cost, low development success, cost-disciplined health-care policies, and intense competition demand an efficient…

CertaraDecember 1, 2011

Publication

Therapeutic Index of Anticoagulants for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose-response Meta-analysis

Information on the comparative effectiveness of drugs is crucial for drug development decisions, in addition…

CertaraDecember 1, 2011

Publication

A Dose-response Meta-analysis for Quantifying Relative Efficacy of Biologics in Rheumatoid Arthritis

We present a dose-response meta-analysis to quantify relative efficacy of biologic disease-modifying antirheumatic drugs (DMARDs)…

CertaraDecember 1, 2011

Publication

Application of a Systems Approach to the Bottom-up Assessment of Pharmacokinetics in Obese Patients: Expected Variations in Clearance

The maintenance dose of a drug is dependent on drug clearance, and thus any biochemical…

CertaraDecember 1, 2011

Publication

Reducing Systems Biology to Practice in Pharmaceutical Company Research: Selected Case Studies

Reviews of the productivity of the pharmaceutical industry have concluded that the current business model…

CertaraNovember 18, 2011

Publication

The Proton Pump Inhibitor, Omeprazole, but not Lansoprazole or Pantoprazole, is a Metabolism-dependent Inhibitor of CYP2C19: Implications for Coadministration with Clopidogrel

As a direct-acting inhibitor of CYP2C19 in vitro, lansoprazole is more potent than omeprazole and…

CertaraNovember 1, 2011

Publication

Determination of Time-dependent Inactivation of CYP3A4 in Cryopreserved Human Hepatocyte and Assessment of Human Drug-drug Interactions

Assessment of time-dependent inhibition (TDI), especially CYP3A4, is an important parameter for preclinical and clinical…

CertaraNovember 1, 2011

Publication

Pharmacokinetics of Voriconazole Administered Concomitantly with Fluconazole and Population-based Simulation for Sequential Use

In clinical practice, antifungal therapy may be switched from fluconazole to voriconazole; such sequential use…

CertaraNovember 1, 2011

Publication

Effect of Different Durations and Formulations of Diltiazem on the Single-dose Pharmacokinetics of Midazolam: How Long Do We Go?

Understanding how inhibition of cytochrome P4503A (CYP3A) affects the metabolism of a new drug is…

CertaraNovember 1, 2011

Model Informed Drug Development

Population Pharmacokinetic-pharmacodynamic-disease Progression Model for Effects of Anakinra in Lewis Rats with Collagen-induced Arthritis

Model-based Meta-analysis for Comparative Efficacy and Safety: Application in Drug Development and Beyond

Therapeutic Index of Anticoagulants for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose-response Meta-analysis

A Dose-response Meta-analysis for Quantifying Relative Efficacy of Biologics in Rheumatoid Arthritis

Application of a Systems Approach to the Bottom-up Assessment of Pharmacokinetics in Obese Patients: Expected Variations in Clearance

Reducing Systems Biology to Practice in Pharmaceutical Company Research: Selected Case Studies

The Proton Pump Inhibitor, Omeprazole, but not Lansoprazole or Pantoprazole, is a Metabolism-dependent Inhibitor of CYP2C19: Implications for Coadministration with Clopidogrel

Determination of Time-dependent Inactivation of CYP3A4 in Cryopreserved Human Hepatocyte and Assessment of Human Drug-drug Interactions

Pharmacokinetics of Voriconazole Administered Concomitantly with Fluconazole and Population-based Simulation for Sequential Use

Effect of Different Durations and Formulations of Diltiazem on the Single-dose Pharmacokinetics of Midazolam: How Long Do We Go?

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