Application of Physiologically-based Pharmacokinetic Model to Predict Tramadol Concentration in Human Milk
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Authors: Trevor Johnson
Prediction of Liver Volume—A Population-based Approach to Meta-analysis of Pediatric, Adult, and Geriatric Populations—An Update
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Predicting Variations in Drug Clearance in Obese Patients Using Modeling and Simulation
Many physiological changes are associated with obesity and can potentially impact pharmacokinetics (PK). This can require adjustments to be made to the standard doses for normal weight patients in order to ensure safety and efficacy of drug therapy. Dosing of specific drugs in this population is dependent on their physico-chemistry as well as changes in body […]
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PBPK Modeling & SimulationCertara’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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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 of this study were to collate literature data on the pharmacokinetics of biliary excretion of drugs used in pediatrics and to apply a physiologically-based pharmacokinetic (PBPK) model to predict their systemic clearance (CL) with a view to elucidating age-related changes […]
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Learning from Failure: Leveraging Biosimulation for Pediatric Drug Development Success
The high rate of trial failures, increasing regulatory demands, and ethical imperatives all require a reexamination of the current approach to pediatric drug development. Biosimulation is a proven approach that will help optimize trial design and inform the drug label. This approach can support global regulatory strategies that increase the likelihood of success for pediatric drug development programs.
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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 cerebrospinal fluid (CSF) compartments has been developed and incorporated into a whole body physiologically-based pharmacokinetic (PBPK) model within the Simcyp Simulator. The model assumptions, structure, governing equations and system parameters are described. The model in particular considers the anatomy and […]
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Development of physiologically-based pharmacokinetic model (PBPK) to evaluate the relative systemic exposure to quetiapine after administration of IR and XR formulations to adults, children and adolescents
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Drug Clearance in Obese Patients: Shall We Expect Variations?
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Application of Physiologically-based Pharmacokinetic (PBPK) Modeling for Prediction of the Exposure of Buprenorphine in Neonates: Incorporation of CYP3A4 and UGT1A1 Ontogenies
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Towards mechanistic simulation and prediction of bioequivalence studies of topical formulations case study with two diclofenac formulations
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Mechanistic modeling of dermal drug absorption using the Simcyp Multi-phase Multi-layer MechDermA model: Case study of a transdermal patch formulation of weak base drug timolol
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Prediction of the Increased Exposure to Drugs in Liver Cirrhosis: A Systems Biology Approach Integrating Prior Information on Disease with In Vitro In Vitro Data on Drug Disposition
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Mechanistic Models of Human Pharmacokinetics to Predict the Effects of Liver Cirrhosis on the Clearance of Nine Drugs
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Physiologically-based Pharmacokinetics (PBPK) With and Without Diffusion Limited Permeability: Modeling Drug Concentration-Time Profile in Brain
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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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Prediction of serum and cerebrospinal fluid concentrations of carbamazepine: An application of parameter estimation and the permeability limited 4-compartment brain model in Simcyp®
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Mechanistic Models of Human Pharmacokinetics to Predict the Effects of Liver Cirrhosis on the Clearance of Nine Drugs
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Cross-Talk between modeling platforms: (B) application of the SBGN standard to a minimal PBPK model
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