Model Informed Drug Development Archives

Publication

Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment

Avibactam is a non-β-lactam β-lactamase inhibitor intended for use as a fixed-dose combination with ceftazidime…

CertaraJuly 12, 2016

Publication

A Tutorial on Pharmacodynamic Scripting Facility in Simcyp

The Simcyp® Simulator provides a framework for mechanistic Physiologically-Based Pharmacokinetic/Pharmacodynamic modelling of potentially interacting drugs.…

CertaraJuly 9, 2016

Publication

More Power to OATP1B1: An Evaluation of Sample Size in Pharmacogenetic Studies Using a Rosuvastatin PBPK Model for Intestinal, Hepatic, and Renal Transporter-mediated Clearances

Rosuvastatin is a substrate of choice in clinical studies of organic anion-transporting polypeptide (OATP)1B1- and…

CertaraJuly 1, 2016

Publication

Short-term Efficacy Reliably Predicts Long-term Clinical Benefit in Rheumatoid Arthritis Clinical Trials as Demonstrated by Model-based Meta-analysis

The objective of this study was to assess the relationship between short-term and long-term treatment…

CertaraJuly 1, 2016

Publication

Potential Sources of Inter-subject Variability in Monoclonal Antibody Pharmacokinetics

Understanding inter-subject variability in drug pharmacokinetics and pharmacodynamics is important to ensure that all patients…

CertaraJuly 1, 2016

Publication

Examining the Use of a Mechanistic Model to Generate an In Vivo/In Vitro Correlation: Journey Through a Thought Process

CertaraJune 16, 2016

Publication

Pharmacokinetic Profile of Defibrotide in Patients with Renal Impairment

Hepatic veno-occlusive disease, also called sinusoidal obstruction syndrome (VOD/SOS), is an unpredictable, potentially life-threatening complication…

CertaraJune 11, 2016

Publication

Pharmacokinetics and Tissue Elimination of Funixin in Veal Calves

OBJECTIVE To describe plasma pharmacokinetic parameters and tissue elimination of flunixin in veal calves. ANIMALS…

CertaraJune 1, 2016

Publication

Development of a Permeability-limited Model of the Human Brain and Cerebrospinal Fluid (CSF) to Integrate Known Physiological and Biological Knowledge: Estimating Time Varying CSF Drug Concentrations and Their Variability Using In Vitro Data

A 4-compartment permeability-limited brain (4Brain) model consisting of brain blood, brain mass, cranial and spinal…

CertaraJune 1, 2016

Publication

Metformin and Cimetidine: Physiologically-based Pharmacokinetic Modeling to Investigate Transporter Mediated Drug–drug Interactions

CertaraJune 1, 2016

Model Informed Drug Development

Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment

A Tutorial on Pharmacodynamic Scripting Facility in Simcyp

More Power to OATP1B1: An Evaluation of Sample Size in Pharmacogenetic Studies Using a Rosuvastatin PBPK Model for Intestinal, Hepatic, and Renal Transporter-mediated Clearances

Short-term Efficacy Reliably Predicts Long-term Clinical Benefit in Rheumatoid Arthritis Clinical Trials as Demonstrated by Model-based Meta-analysis

Potential Sources of Inter-subject Variability in Monoclonal Antibody Pharmacokinetics

Examining the Use of a Mechanistic Model to Generate an In Vivo/In Vitro Correlation: Journey Through a Thought Process

Pharmacokinetic Profile of Defibrotide in Patients with Renal Impairment

Pharmacokinetics and Tissue Elimination of Funixin in Veal Calves

Development of a Permeability-limited Model of the Human Brain and Cerebrospinal Fluid (CSF) to Integrate Known Physiological and Biological Knowledge: Estimating Time Varying CSF Drug Concentrations and Their Variability Using In Vitro Data

Metformin and Cimetidine: Physiologically-based Pharmacokinetic Modeling to Investigate Transporter Mediated Drug–drug Interactions

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