Model Informed Drug Development Archives

Publication

Cytochrome P450 Turnover: Regulation of Synthesis and Degradation, Methods for Determining Rates, and Implications for the Prediction of Drug Interactions

In vivo enzyme levels are governed by the rates of de novo enzyme synthesis and…

Certara2016 年 6 月 1 日

On-Demand Webinar

Can QSP Save Lives? Lessons from the Bial Trial Debacle

One of the biggest challenges for the pharmaceutical industry is the high rate of drug…

Certara2016 年 5 月 4 日

Publication

Optimization of Vancomycin Dosing Regimens to Achieve Therapeutic Targets in Critically Ill Patients in Thailand

It is essential to rapidly achieve therapeutic vancomycin concentrations in critically ill patients with gram-positive…

Certara2016 年 5 月 1 日

Publication

A Six-stage Workflow for Robust Application of Systems Pharmacology

Quantitative and systems pharmacology (QSP) is increasingly being applied in pharmaceutical research and development. One…

Certara2016 年 5 月 1 日

Brochure

Academic Licenses

Simcyp grants academic licenses for the Simcyp Simulator to centers of excellence in research related…

Certara2016 年 4 月 27 日

Publication

Population Pharmacokinetic/Pharmacodynamic Modeling of Tumor Growth Kinetics in Medullary Thyroid Cancer Patients Receiving Cabozantinib

Nonlinear mixed effects models were developed to describe the relationship between cabozantinib exposure and target…

Certara2016 年 4 月 27 日

Publication

Pharmacokinetics and Pharmacodynamics of Gamithromycin in Pulmonary Epithelial Lining Fluid in Naturally Occurring Bovine Respiratory Disease in Multisource Commingled Feedlot Cattle

The objectives of this study were to determine (i) whether an association exists between individual…

Certara2016 年 4 月 1 日

Publication

Breast Cancer Resistance Protein Abundance, but Not mRNA Expression, Correlates with Estron e-3-Sulfate Transport in Caco-2

Transporter mRNA and protein expression data are used to extrapolate in vitro transporter kinetics to in…

Certara2016 年 4 月 1 日

Publication

Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia

X-linked hypophosphatemia (XLH) is an inherited metabolic bone disease with abnormally elevated serum FGF23 resulting…

Certara2016 年 4 月 1 日

Publication

A Critical Evaluation of the Experimental Design of Studies of Mechanism-based Enzyme Inhibition, with Implications for In Vitro-In Vivo Extrapolation

The published literature on mechanism based inhibition (MBI) of CYPs was evaluated with respect to…

Certara2016 年 4 月 1 日

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Cytochrome P450 Turnover: Regulation of Synthesis and Degradation, Methods for Determining Rates, and Implications for the Prediction of Drug Interactions

Can QSP Save Lives? Lessons from the Bial Trial Debacle

Optimization of Vancomycin Dosing Regimens to Achieve Therapeutic Targets in Critically Ill Patients in Thailand

A Six-stage Workflow for Robust Application of Systems Pharmacology

Academic Licenses

Population Pharmacokinetic/Pharmacodynamic Modeling of Tumor Growth Kinetics in Medullary Thyroid Cancer Patients Receiving Cabozantinib

Pharmacokinetics and Pharmacodynamics of Gamithromycin in Pulmonary Epithelial Lining Fluid in Naturally Occurring Bovine Respiratory Disease in Multisource Commingled Feedlot Cattle

Breast Cancer Resistance Protein Abundance, but Not mRNA Expression, Correlates with Estron e-3-Sulfate Transport in Caco-2

Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia

A Critical Evaluation of the Experimental Design of Studies of Mechanism-based Enzyme Inhibition, with Implications for In Vitro-In Vivo Extrapolation

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