Modeling and Simulation - PK/PD Archives | Page 39 of 41

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

Knowledge Base

What is Pharmacodynamics?

Starting with definitions is always helpful… so after defining pharmacokinetics, a definition for pharmacodynamics is…

CertaraMay 24, 2010

Knowledge Base

What is Pharmacokinetics?

You might think this is a simple question, especially for an expert in pharmacokinetics. Well,…

CertaraMay 16, 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

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

Publication

Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-like Peptide-2 Analog in Neonates and Infants with Short-bowel Syndrome

Teduglutide, a synthetic glucagon-like peptide-2 (GLP-2) analog with activity relating to the regeneration, maintenance, and…

CertaraDecember 1, 2009

Publication

Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs

Concentration-QT (C-QT) modeling has been conducted for multiple compounds at various stages of development in…

CertaraNovember 1, 2009

Publication

Model-based Prediction of Phase 3 Overall Survival in Colorectal Cancer on the Basis of Phase 2 Tumor Dynamics

We developed a drug-disease simulation model to predict antitumor response and overall survival in phase…

CertaraSeptember 1, 2009

Publication

On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies: Toward a New Paradigm to Design and Evaluate Phase 2 Studies

Drug-independent models that link biomarker response to clinical end points are critical to support early…

CertaraAugust 1, 2009

Publication

Pharmacokinetic Analysis of Capsaicin After Topical Administration of a High-concentration Capsaicin Patch to Patients With Peripheral Neuropathic Pain

Capsaicin, a pungent compound in chili peppers, is a highly selective agonist for the transient…

CertaraAugust 1, 2009

Modeling and Simulation – PK/PD

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

What is Pharmacodynamics?

What is Pharmacokinetics?

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

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

Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-like Peptide-2 Analog in Neonates and Infants with Short-bowel Syndrome

Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs

Model-based Prediction of Phase 3 Overall Survival in Colorectal Cancer on the Basis of Phase 2 Tumor Dynamics

On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies: Toward a New Paradigm to Design and Evaluate Phase 2 Studies

Pharmacokinetic Analysis of Capsaicin After Topical Administration of a High-concentration Capsaicin Patch to Patients With Peripheral Neuropathic Pain

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