Model Informed Drug Development Archives

Publication

Sex Differences in the Clearance of CYP3A4 Substrates: Exploring Possible Reasons for the Substrate Dependency and Lack of Consensus

Sex differences in the clearance of substrates of Cytochrome P4503A (CYP3A4) have been reported frequently…

CertaraJuly 1, 2012

Publication

Prediction of Concentration-time Profile and Its Inter-individual Variability Following the Dermal Drug Absorption

Estimation of systemic exposure after absorption of any xenobiotic from the skin is very important…

CertaraJuly 1, 2012

Publication

Physiologically-based Pharmacokinetics Joined with In Vitro-In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology

Classic pharmacokinetics (PK) rarely takes into account the full knowledge of physiology and biology of…

CertaraJuly 1, 2012

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

Model Informed Drug Development

Sex Differences in the Clearance of CYP3A4 Substrates: Exploring Possible Reasons for the Substrate Dependency and Lack of Consensus

Prediction of Concentration-time Profile and Its Inter-individual Variability Following the Dermal Drug Absorption

Physiologically-based Pharmacokinetics Joined with In Vitro-In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology

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

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