Application of Physiologically-based Pharmacokinetic Modeling to Predict Caffeine Pharmacokinetics in a Preterm Neonatal Population
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Authors: Trevor Johnson
Prediction of the Impact of Pregnancy on Sotaolol Pharmacokinetics Using the Simcyp Pregnancy PBPK Model
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Application of Physiologically-based Pharmacokinetic Model to Predict Tramadol Concentration in Human Milk
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Does Birth Have an Effect on Gestational Trajectory of UGT2B7 Activity in Neonates?
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Application of Physiologically-based Pharmacokinetic Modeling for Prediction of Buprenorphine Exposure in Subjects with Hepatic Impairment
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On Early Pediatric Study Design: Sample Size Calculation Using a PBPK Approach Within the Simcyp Simulator
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Predictive Performance of Physiologically-based Pharmacokinetic (PBPK) Modeling of Sufentanil in Children
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Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Predict Ondansetron Pharmacokinetics in Children
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Prediction of Liver Volume—A Population-based Approach to Meta-analysis of Pediatric, Adult, and Geriatric Populations—An Update
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Does Birth Have an Effect on UGT2B7 Activity in Neonates?
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Changes in Liver Volume II—A Population-based Approach to Meta-analysis of Pediatric, Adult and Geriatric Populations—An Update
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Prediction of Large Molecule Clearance in Children Using Allometry vs. PBPK—Erythropoietin as a Case Example
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Application of PBPK Approach to Investigate the Role of Intestinal and Hepatic P-glycoprotein in Digoxin Disposition in Newborn Children. Is there an Ontogeny Function?
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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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Assessing the Impact of Liver or Kidney Disease on Pharmacokinetics
Impaired hepatic or renal function can have a major impact on pharmacokinetics. There is a high risk of adverse events in patients with these conditions. Major pharmaceutical companies and drug regulatory agencies use physiologically-based pharmacokinetic (PBPK) modeling in virtual populations to investigate the impact of hepatic or renal impairment on drug exposure as a supplement to […]
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PBPK Modeling & SimulationPrediction of Cutaneous PK Profiles After Topical Application—A Comparison Between the Novel MPML-MechDermA Model and the Current MechDermA Model in Simcyp Simulator Case Study: Erythromycin
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