Model Informed Drug Development Archives

Publication

A Mechanistic Pharmacokinetic Model to Assess Modified Oral Drug Bioavailability Post Bariatric Surgery in Morbidly Obese Patients: Interplay Between CYP3A Gut Wall Metabolism, Permeability, and Dissolution

Due to the multi-factorial physiological implications of surgery, attempts to explain trends in oral bioavailability following bariatric…

CertaraJune 11, 2012

Publication

Prediction of Drug Clearance in a Smoking Population: Modeling the Impact of Variable Cigarette Consumption on the Induction of CYP1A2

The objective of this study was to derive estimates of CYP1A2 abundance as a function…

CertaraJune 1, 2012

Publication

Noninvasive Real-time Fluorescence Imaging of the Lymphatic Uptake of BSA-IRDye 680 Conjugate Administered Subcutaneously in Mice

The goal of our studies was to determine lymphatic uptake of bovine serum albumin (BSA)…

CertaraMay 1, 2012

Publication

Modeling and Simulation of Edoxaban Exposure and Response Relationships in Patients with Atrial Fibrillation

Edoxaban is a novel, orally available, highly specific direct inhibitor of factor Xa and is…

CertaraMay 1, 2012

Publication

Placebo Response Changes Depending on the Neuropathic Pain Syndrome: Results of a Systematic Review and Meta-analysis

The purpose of this study was to compare placebo responses in neuropathic pain syndromes through systematic…

CertaraApril 1, 2012

Publication

PEGylation of a Factor VIII-phosphatidylinositol Complex: Pharmacokinetics and Immunogenicity in Hemophilia A Mice

Hemophilia A is an X-linked bleeding disorder caused by the deficiency of factor VIII (FVIII).…

CertaraMarch 1, 2012

Publication

Screening of Chemicals for Human Bioaccumulative Potential with a Physiologically-based Toxicokinetic Model

Human bioaccumulative potential is an important element in the risk assessment of chemicals. Due to…

CertaraMarch 1, 2012

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

Model Informed Drug Development

A Mechanistic Pharmacokinetic Model to Assess Modified Oral Drug Bioavailability Post Bariatric Surgery in Morbidly Obese Patients: Interplay Between CYP3A Gut Wall Metabolism, Permeability, and Dissolution

Prediction of Drug Clearance in a Smoking Population: Modeling the Impact of Variable Cigarette Consumption on the Induction of CYP1A2

Noninvasive Real-time Fluorescence Imaging of the Lymphatic Uptake of BSA-IRDye 680 Conjugate Administered Subcutaneously in Mice

Modeling and Simulation of Edoxaban Exposure and Response Relationships in Patients with Atrial Fibrillation

Placebo Response Changes Depending on the Neuropathic Pain Syndrome: Results of a Systematic Review and Meta-analysis

PEGylation of a Factor VIII-phosphatidylinositol Complex: Pharmacokinetics and Immunogenicity in Hemophilia A Mice

Screening of Chemicals for Human Bioaccumulative Potential with a Physiologically-based Toxicokinetic Model

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

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