A Whole Body Physiologically-based Pharmacokinetic Model for Antibody Drug Conjugates – Model Development and Validation in Rat
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Authors: Iain Gardner
New Tools Support Developing Better TB Drugs
Tuberculosis (TB)—caused by infection with the mycobacterium Mycobacterium tuberculosis—is one of the top 10 leading causes of death worldwide with a total of 1.8 million people dying from the disease in 2015. TB is also the leading cause of death in HIV-infected individuals. TB usually attacks the lungs but can infect any part of the […]
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PBPK Modeling & SimulationA Multi-compartment Liver Model for the Prediction of Toxicokinetics
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PBPK Modeling of Target Organ Concentrations for Reverse Dosimetry
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Certara’s Best of Blogs 2015
A selection of short essays from our blog, written to empower our customers with biosimulation 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.
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A Novel Mechanistic Approach to Predict the Steady State Volume of Distribution (Vss) Using the Fick-Nernst-Placnk Equation
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Development of a Novel Multi-compartment Granuloma Model to Predict Local Drug Distribution and Its Impact on Pharmacodynamics and Disease Progression in Tuberculosis
Objectives: One of the hallmarks of pulmonary tuberculosis (TB) is the formation of granulomas, heterogeneous lesions composed of macrophage and neutrophil rich peripheral regions and a necrotic core, in the lungs of the infected host. Anti-TB drugs must penetrate these lesions to exert their effects. This work aimed to extend a permeability-limited lung model [1] […]
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Prediction of Drug-drug Interactions Arising From CYP3A Induction Using a Physiologically-based Dynamic Model
Using physiologically-based pharmacokinetic modeling, we predicted the magnitude of drug-drug interactions (DDIs) for studies with rifampicin and seven CYP3A4 probe substrates administered i.v. (10 studies) or orally (19 studies). The results showed a tendency to underpredict the DDI magnitude when the victim drug was administered orally. Possible sources of inaccuracy were investigated systematically to determine […]
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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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Externally Funded Research Projects
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Towards Quantitative Prediction of Disease-Drug Interactions Using A Physiologically-based Pharmacokinetic Modeling Approach: Suppression of CYP1A2 by IL-6
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Application of A Multi-Compartment Permeability Limited Lung Model to Predict Lung Concentrations of Anti-Tuberculosis Drugs in Virtual Human Subjects
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A Minimal Physiologically-based Pharmacokinetic Model of IgG: Impact of Inclusion of 2:1 FcRn IgG Binding Stoichiometry and a Proportion of CL That is independent of FcRn Binding
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Modeling the Binding Kinetics of Bispecific Antibodies under the Framework of a Minimal Human PBPK Model
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Extending TMDD Models to Simulate the PK of mAbs that Bind to Both a Cell Surface Antigen on Leukocytes and Shed Antigen in the Circulation
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Application of PBPK Modeling for Prediction of FMO Metabolism Using Benzydamine as a Probe for FMO3
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An Investigation into the use of an Empirical Scaling Strategy for the Prediction of In Vivo Aldehyde Oxidase Clearance
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PBPK Modeling of Ester-prodrugs: Example of Oseltamivir for incorporating Organ and Plasma Esterase Metabolism and Assessing CES1 Population Genetic Impact
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A mechanistic minimal PBPK model to predict distribution and subcutaneous absorption of therapeutic proteins
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Prediction of the Oral Clearance of Isoniazid in Virtual Subjects With Different Nat-2 Acetylator Status
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