Prediction of the Pharmacokinetics of Renally-excreted Antiretrovirals in Older Patients, Using Physiologically-based Pharmacokinetic (PBPK) Modeling
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Authors: Manoranjenni Chetty
Certara’s Best of Blogs 2016
A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.
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Predicting the Pharmacokinetic Changes in Fluoxetine During Pregnancy
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Application of a PBPK/PD Model to Describe the Impact of CYP2C19 Polymorphisms on the Pharmacokinetics and Response to Clopidogrel
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Using PBPK Models to Optimize Antiviral Dosing at the Point of Care
The use of physiologically-based pharmacokinetic (PBPK) modeling for drug development is well-established and is now routinely used by the pharmaceutical industry, regulators, and researchers. In this blog post, I’ll discuss a novel application that combined PBPK and Bayesian modeling to help clinicians optimize dosing at the point of patient care. This application was used to […]
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PBPK Modeling & SimulationPotential 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 attain suitable drug exposure to achieve efficacy and avoid toxicity. Inter-subject variability in the pharmacokinetics of therapeutic monoclonal antibodies (mAbs) is generally moderate to high; however, the factors responsible for the high inter-subject variability have not been comprehensively reviewed. In […]
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Getting at the HAART of Precision Dosing: Using PBPK Models to Optimize Dosing of an Antiviral
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used as part of highly active antiretroviral therapy (HAART) for the treatment of a human immunodeficiency virus (HIV) type 1. It is primarily metabolized by CY2B6. A standard dose of efavirenz has been associated with serious adverse reactions in poor metabolizers (PMs) of CYP2B6, necessitating a reduction […]
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A Whole Body PBPK Model to Predict Plasma and Tissue Interstitial Fluid Concentrations in Humans for Proteins with a Range of Sizes
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Emerging Covariates on the Pharmacokinetics of Monoclonal Antibodies: Do Current PBPK Models Account for the Significant Covariates Identified in POPPK Studies?
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Application of PBPK and Bayesian Modeling for Prediction of the Likelihood of Individual Patients Experiencing Serious Adverse Reactions to a Standard Dose of Efavirenz
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Use of a test dose of efavirenz to predict the likelihood of individual patients experiencing serious adverse reactions to a standard dose
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Predicting the Effect of CYP2D6 Polymorphism on Pharmacodynamic Response to Metoprolol
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PBPK/PD approach to discern potential sex and ethnic differences in the time course of QT prolongation following quinidine administration: Caucasian vs Korean healthy populations
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Application of a Physiologically-based Pharmacokinetic/Pharmacodynamic (PBPK/PD) Model to Investigate the Effect of OATP1B1 Genotypes on the Cholesterol Synthesis Inhibitory Effect of Rosuvastatin
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Application of a PBPK/PD model describing the change in systolic blood pressure following administration of immediate release and controlled release nifedipine formulations
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Prediction of the Hypnotic Effects of Zolpidem by Extrapolation of a Mechanism-based PKPD Model Developed for Triazolam in Healthy Volunteers
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Application of Simcyp to Simulate PK as well as Pharmacological Response of Nifedipine in Japanese and Caucasian Populations
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Development of a Minimal-PBPK Model for Simulating Monoclonal Antibody Pharmacokinetics in Human
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Application of the target-mediated drug disposition approach within a minimal PBPK model to investigate pharmacokinetics of therapeutic proteins
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Are PBPK models reporting the right Cmax? Central venous versus peripheral site
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