Model Informed Drug Development Archives

Publication

Use of a Multistaged Time-dependent Inhibition Assay to Assess the Impact of Intestinal Metabolism on Drug-drug Interaction Potential

In early discovery, compounds are often eliminated because of their potential to undergo metabolic activation…

CertaraMarch 1, 2012

Publication

Application of IVIVE and PBPK Modeling in Prospective Prediction of Clinical Pharmacokinetics: Strategy and Approach During the Drug Discovery Phase with Four Case Studies

Prospective simulations of human pharmacokinetic (PK) parameters and plasma concentration-time curves using in vitro in…

CertaraMarch 1, 2012

Publication

Evaluation of Methods for Achieving Stable INR in Healthy Subjects During a Multiple-dose Warfarin Study

No consistent method is available for finding stable warfarin maintenance doses and fast stabilization of…

CertaraMarch 1, 2012

Publication

Mechanism-based Population Modeling of the Effects of Vildagliptin on GLP-1, Glucose, and Insulin in Patients with Type 2 Diabetes

The aim of this study was to build a mechanism-based population pharmacodynamic model to describe…

CertaraMarch 1, 2012

Publication

Population Pharmacokinetic Model for a Novel Oral Hypoglycemic Formed In Vivo: Comparing the Use of Active Metabolite Data Alone Versus Using Data of Upstream and Downstream Metabolites

The purpose of this analysis was to develop a population pharmacokinetic model for CS-917, an…

CertaraMarch 1, 2012

Publication

Physiologically-based Pharmacokinetic (PBPK) Modeling: It is Here to Stay!

Physiologically based pharmacokinetic (PBPK) modeling is an extremely useful approach with the ability to predict…

CertaraMarch 1, 2012

Publication

Interactions Between Buprenorphine and the Protease Inhibitors Darunavir-ritonavir and Fosamprenavir-ritonavir

This study examined drug interactions between buprenorphine, a partial opioid agonist used for opioid dependence…

CertaraFebruary 1, 2012

Publication

Subcutaneous Absorption of Monoclonal Antibodies: Role of Dose, Site of Injection, and Injection Volume on Rituximab Pharmacokinetics in Rats

To determine the effect of dose, the anatomical site of injection, and the injection volume…

CertaraFebruary 1, 2012

Publication

Influence of Route of Administration and Liposomal Encapsulation on Blood and Lymph Node Exposure to the Protein VEGF-C156S

VEGF-C156S is a recombinant form of human vascular endothelial growth factor C (VEGF-C), which targets…

CertaraFebruary 1, 2012

Publication

Effect of Ketoconazole on the Pharmacokinetics of Axitinib in Healthy Volunteers

Axitinib (AG-013736), an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1,…

CertaraFebruary 1, 2012

Model Informed Drug Development

Use of a Multistaged Time-dependent Inhibition Assay to Assess the Impact of Intestinal Metabolism on Drug-drug Interaction Potential

Application of IVIVE and PBPK Modeling in Prospective Prediction of Clinical Pharmacokinetics: Strategy and Approach During the Drug Discovery Phase with Four Case Studies

Evaluation of Methods for Achieving Stable INR in Healthy Subjects During a Multiple-dose Warfarin Study

Mechanism-based Population Modeling of the Effects of Vildagliptin on GLP-1, Glucose, and Insulin in Patients with Type 2 Diabetes

Population Pharmacokinetic Model for a Novel Oral Hypoglycemic Formed In Vivo: Comparing the Use of Active Metabolite Data Alone Versus Using Data of Upstream and Downstream Metabolites

Physiologically-based Pharmacokinetic (PBPK) Modeling: It is Here to Stay!

Interactions Between Buprenorphine and the Protease Inhibitors Darunavir-ritonavir and Fosamprenavir-ritonavir

Subcutaneous Absorption of Monoclonal Antibodies: Role of Dose, Site of Injection, and Injection Volume on Rituximab Pharmacokinetics in Rats

Influence of Route of Administration and Liposomal Encapsulation on Blood and Lymph Node Exposure to the Protein VEGF-C156S

Effect of Ketoconazole on the Pharmacokinetics of Axitinib in Healthy Volunteers

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