Model Informed Drug Development Archives

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

Identification of Cytochrome P450 Isoforms Involved in the Metabolism of Paroxetine and Estimation of Their Importance for Human Paroxetine Metabolism Using a Population-based Simulator

We identify here for the first time the low-affinity cytochrome P450 (P450) isoforms that metabolize…

CertaraMarch 1, 2010

Publication

A Semi-mechanistic Model to Predict the Effects of Liver Cirrhosis on Drug Clearance

Liver cirrhosis is characterized by a decrease in functional hepatocytes, lowered circulating levels of plasma…

CertaraMarch 1, 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

Publication

Prediction of Vss from In Vitro Tissue Binding Studies

To predict volume of distribution at steady-state (Vss), empirical (e.g., allometry) and mechanistic (using physicochemical…

CertaraJanuary 1, 2010

Publication

Population Pharmacokinetics of Teduglutide Following Repeated Subcutaneous Administrations in Healthy Participants and in Patients with Short Bowel Syndrome and Crohn’s Disease

Teduglutide is a GLP-2 analog currently evaluated for the treatment of short bowel syndrome, Crohn's…

CertaraJanuary 1, 2010

Model Informed Drug Development

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

Identification of Cytochrome P450 Isoforms Involved in the Metabolism of Paroxetine and Estimation of Their Importance for Human Paroxetine Metabolism Using a Population-based Simulator

A Semi-mechanistic Model to Predict the Effects of Liver Cirrhosis on Drug Clearance

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

Prediction of Vss from In Vitro Tissue Binding Studies

Population Pharmacokinetics of Teduglutide Following Repeated Subcutaneous Administrations in Healthy Participants and in Patients with Short Bowel Syndrome and Crohn’s Disease

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