Publication Archives

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

Mechanistic Toxicokinetic Model for γ-Hydroxybutyric Acid: Inhibition of Active Renal Reabsorption as a Potential Therapeutic Strategy

γ-Hydroxybutyric acid (GHB), a drug of abuse, exhibits saturable renal clearance and capacity-limited metabolism. The …

CertaraSeptember 1, 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

Confidence Assessment of Predicting Clinical Drug Interactions of Mechanism-based CYP3A Inhibitors Using Simcyp Time-based Approach and a Static Mathematic Model

Accurate prediction of the extent of mechanism-based CYP3A inhibition is critical in determining the timing…

CertaraJuly 1, 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

Selection of Alternative CYP3A4 Probe Substrates for Clinical Drug Interaction Studies Using In Vitro Data and In Vivo Simulation

Understanding the potential for cytochrome P450-mediated drug-drug interactions (DDIs) is a critical step in the drug discovery process. DDIs…

CertaraJune 1, 2010

Publication

Concentration–Effect Relationships for the Drug of Abuse—γ-hydroxybutyric Acid

γ-Hydroxybutyric acid (GHB) is an endogenous neurotransmitter that is abused because of its sedative/hypnotic and…

CertaraJune 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

Population Pharmacokinetic/Pharmacodynamic Model for a C.E.R.A. in Both ESA-naive and ESA-treated Chronic Kidney Disease Patients with Renal Anemia

This study aimed to develop a population pharmacokinetic/pharmacodynamic (PK/PD) model for C.E.R.A., a continuous erythropoietin…

CertaraMay 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

Mechanistic Toxicokinetic Model for γ-Hydroxybutyric Acid: Inhibition of Active Renal Reabsorption as a Potential Therapeutic Strategy

A Pharmacokinetic/Pharmacodynamic Model for Cardiovascular Safety Assessment of R1551

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

Confidence Assessment of Predicting Clinical Drug Interactions of Mechanism-based CYP3A Inhibitors Using Simcyp Time-based Approach and a Static Mathematic Model

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

Selection of Alternative CYP3A4 Probe Substrates for Clinical Drug Interaction Studies Using In Vitro Data and In Vivo Simulation

Concentration–Effect Relationships for the Drug of Abuse—γ-hydroxybutyric Acid

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

Population Pharmacokinetic/Pharmacodynamic Model for a C.E.R.A. in Both ESA-naive and ESA-treated Chronic Kidney Disease Patients with Renal Anemia

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