Publication Archives

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

Physiologically-based Pharmacokinetic Modeling in Pediatric Oncology Drug Development

CertaraJuly 1, 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

How Does the In Vivo Biliary Elimination of Drugs Change with Age? Evidence from In Vitro and Clinical Data Using a Systems Pharmacology Approach

Information on the developmental changes in biliary excretion (BE) of drugs is sparse. The aims…

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

Considering Age Variation When Coining Drugs as High Versus Low Hepatic Extraction Ratio

The hepatic extraction ratio (EH) is commonly considered an "inherent attribute" of drug. It determines…

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

Lessons Learned: Dose Selection of Small Molecule-targeted Oncology Drugs

CertaraJune 1, 2016

Publication

A Tutorial on Pharmacodynamic Scripting Facility in Simcyp

Physiologically-based Pharmacokinetic Modeling in Pediatric Oncology Drug Development

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

How Does the In Vivo Biliary Elimination of Drugs Change with Age? Evidence from In Vitro and Clinical Data Using a Systems Pharmacology Approach

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

Considering Age Variation When Coining Drugs as High Versus Low Hepatic Extraction Ratio

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

Lessons Learned: Dose Selection of Small Molecule-targeted Oncology Drugs

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