Therapeutic Specialties Archives

Publication

Development of a Modeling Framework to Simulate Efficacy Endpoints for Motesanib in Thyroid Cancer Patients

To develop a modeling framework that simulates clinical endpoints (objective response rate and progression-free survival)…

CertaraNovember 1, 2010

Publication

Population Pharmacokinetic/Pharmacodynamic Modeling for the Time Course of Tumor Shrinkage by Motesanib in Thyroid Cancer Patients

To develop a population pharmacokinetic/pharmacodynamic model describing the relationship between motesanib exposure and tumor response…

CertaraNovember 1, 2010

Publication

Randomised, Parallel-group, Multicenter, Multinational Phase 2 Study Comparing Edoxaban, an Oral Factor Xa Inhibitor, with Warfarin for Stroke Prevention in Patients with Atrial Fibrillation

The primary objective of this study was to compare the safety of four fixed-dose regimens…

CertaraSeptember 10, 2010

Publication

A Pharmacokinetic/Pharmacodynamic Model for Cardiovascular Safety Assessment of R1551

Pharmacokinetic-pharmacodynamic relationships are crucial in understanding a drug's arrhythmogenic potential. Models assist to quantitatively relate…

CertaraAugust 21, 2010

Publication

A Modeling and Simulation Framework to Support Early Clinical Drug Development Decisions in Oncology

CertaraJuly 13, 2010

Publication

Relationship Between Exposure to Sunitinib and Efficacy and Tolerability Endpoints in Patients with Cancer: Results of a Pharmacokinetic/Pharmacodynamic Meta-analysis

In this pharmacokinetic/pharmacodynamic meta-analysis, we investigated relationships between clinical endpoints and sunitinib exposure in patients…

CertaraJuly 1, 2010

Publication

Pharmacology and Safety of Glycerol Phenylbutyrate in Healthy Adults and Adults with Cirrhosis

Phenylbutyric acid (PBA), which is approved for treatment of urea cycle disorders (UCDs) as sodium…

CertaraJune 1, 2010

Publication

Under-reporting of Venous and Arterial Thrombotic Events in Randomized Clinical Trials: A Meta-analysis

For the detection of unwanted outcomes of new interventions, physicians rely on adverse event reporting.…

CertaraMarch 1, 2010

Publication

Detection of Lymph Node Metastases by Gadolinium-enhanced Magnetic Resonance Imaging: Systematic Review and Meta-analysis

Gadolinium-based contrast agents are used with magnetic resonance imaging (MRI) to highlight tumor vascularity in…

CertaraFebruary 24, 2010

Publication

The Use of Biosimulation in the Design of a Novel Multilevel Weight Loss Maintenance Program for Overweight Children

Weight loss outcomes achieved through conventional behavior change interventions are prone to deterioration over time.…

CertaraFebruary 18, 2010

Therapeutic Specialties

Development of a Modeling Framework to Simulate Efficacy Endpoints for Motesanib in Thyroid Cancer Patients

Population Pharmacokinetic/Pharmacodynamic Modeling for the Time Course of Tumor Shrinkage by Motesanib in Thyroid Cancer Patients

Randomised, Parallel-group, Multicenter, Multinational Phase 2 Study Comparing Edoxaban, an Oral Factor Xa Inhibitor, with Warfarin for Stroke Prevention in Patients with Atrial Fibrillation

A Pharmacokinetic/Pharmacodynamic Model for Cardiovascular Safety Assessment of R1551

A Modeling and Simulation Framework to Support Early Clinical Drug Development Decisions in Oncology

Relationship Between Exposure to Sunitinib and Efficacy and Tolerability Endpoints in Patients with Cancer: Results of a Pharmacokinetic/Pharmacodynamic Meta-analysis

Pharmacology and Safety of Glycerol Phenylbutyrate in Healthy Adults and Adults with Cirrhosis

Under-reporting of Venous and Arterial Thrombotic Events in Randomized Clinical Trials: A Meta-analysis

Detection of Lymph Node Metastases by Gadolinium-enhanced Magnetic Resonance Imaging: Systematic Review and Meta-analysis

The Use of Biosimulation in the Design of a Novel Multilevel Weight Loss Maintenance Program for Overweight Children

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