Model Informed Drug Development Archives

Publication

Lost in Centrifugation: Accounting for Transporter Protein Losses in Quantitative Targeted Absolute Proteomics

In drug development, considerable efforts are made to extrapolate from in vitro and preclinical findings…

webdev2014 年 10 月 1 日

Publication

Time Course of Bone Mineral Density Changes with Denosumab Compared with Other Drugs in Postmenopausal Osteoporosis: A Dose-response-based Meta-analysis

Our objective was to compare the time course of bone mineral density (BMD) changes at…

webdev2014 年 10 月 1 日

Publication

Cardiac Safety Research Consortium: Can the Thorough QT/QTc Study Be Replaced by Early QT Assessment in Routine Clinical Pharmacology Studies? Scientific Update and a Research Proposal for a Path Forward

The International Conference on Harmonization E14 guidance for the clinical evaluation of QT/QTc interval prolongation…

webdev2014 年 9 月 1 日

Publication

Deciding on Success Criteria for Predictability of Pharmacokinetic Parameters from In Vitro Studies: An Analysis Based on In Vivo Observations

Prediction accuracy of pharmacokinetic parameters is often assessed using prediction fold error, i.e., being within 2-, 3-, or…

webdev2014 年 9 月 1 日

Publication

Development of Physiologically-based Pharmacokinetic Model to Evaluate the Relative Systemic Exposure to Quetiapine After Administration of IR and XR Formulations to Adults, Children, and Adolescents

Quetiapine is an atypical antipsychotic drug with a high permeability, moderate solubility and defined as…

webdev2014 年 9 月 1 日

Publication

Assessment of Tumor Growth Inhibition Metrics to Predict Overall Survival

Modeling and simulation is proposed to support drug development phase transitions in oncology. Longitudinal tumor-size…

webdev2014 年 8 月 1 日

Publication

Interaction Between Domperidone and Ketoconazole: Toward Prediction of Consequent QTc Prolongation Using Purely In Vitro Information

We aimed to investigate the application of combined mechanistic pharmacokinetic (PK) and pharmacodynamic (PD) modeling…

webdev2014 年 8 月 1 日

Publication

Population Pharmacokinetic Analysis of Dutogliptin, a Selective Dipeptidyl Peptidase-4 Inhibitor

Dutogliptin is a selective dipeptidyl peptidase-4 inhibitor shown to be efficacious and safe in patients…

webdev2014 年 7 月 14 日

Publication

Simulation of Monoclonal Antibody Pharmacokinetics in Humans Using a Minimal Physiologically-based Model

Compared to small chemical molecules, antibodies and Fc-containing derivatives (mAbs) have unique pharmacokinetic behavior characterized by…

webdev2014 年 7 月 9 日

Publication

Application of a Physiologically-based Pharmacokinetic Model to Predict OATP1B1-related Variability in Pharmacodynamics of Rosuvastatin

Typically, pharmacokinetic-pharmacodynamic (PK/PD) models use plasma concentration as the input that drives the PD model. However, interindividual variability in…

webdev2014 年 7 月 9 日

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Lost in Centrifugation: Accounting for Transporter Protein Losses in Quantitative Targeted Absolute Proteomics

Time Course of Bone Mineral Density Changes with Denosumab Compared with Other Drugs in Postmenopausal Osteoporosis: A Dose-response-based Meta-analysis

Cardiac Safety Research Consortium: Can the Thorough QT/QTc Study Be Replaced by Early QT Assessment in Routine Clinical Pharmacology Studies? Scientific Update and a Research Proposal for a Path Forward

Deciding on Success Criteria for Predictability of Pharmacokinetic Parameters from In Vitro Studies: An Analysis Based on In Vivo Observations

Development of Physiologically-based Pharmacokinetic Model to Evaluate the Relative Systemic Exposure to Quetiapine After Administration of IR and XR Formulations to Adults, Children, and Adolescents

Assessment of Tumor Growth Inhibition Metrics to Predict Overall Survival

Interaction Between Domperidone and Ketoconazole: Toward Prediction of Consequent QTc Prolongation Using Purely In Vitro Information

Population Pharmacokinetic Analysis of Dutogliptin, a Selective Dipeptidyl Peptidase-4 Inhibitor

Simulation of Monoclonal Antibody Pharmacokinetics in Humans Using a Minimal Physiologically-based Model

Application of a Physiologically-based Pharmacokinetic Model to Predict OATP1B1-related Variability in Pharmacodynamics of Rosuvastatin

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