Model Informed Drug Development Archives

刊物

Precision Criteria to Derive Sample Size When Designing Pediatric Pharmacokinetics Studies: Which Measure of Variability Should be Used?

A new approach for calculation of sample size in pediatric clinical pharmacokinetic studies was suggested based on desired precision for a pharmacokinetic parameter…

Certara2014 年 3 月 1 日

Publication

Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers

Axitinib is a potent and selective second generation inhibitor of vascular endothelial growth factor receptors…

Certara2014 年 2 月 21 日

Publication

A Model-based Meta-analysis to Compare Efficacy and Tolerability of Tramadol and Tapentadol for the Treatment of Chronic Non-malignant Pain

Pain is a major symptom in many medical conditions which can be relieved thanks to…

Certara2014 年 2 月 13 日

Publication

A Systems Pharmacology Perspective on the Clinical Development of Fatty Acid Amide Hydrolase Inhibitors for Pain

The level of the endocannabinoid anandamide is controlled by fatty acid amide hydrolase (FAAH). In…

Certara2014 年 1 月 15 日

刊物

The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?

A collaboration between the Consortium for Innovation and Quality in Pharmaceutical Development and the Cardiac…

Certara2014 年 1 月 1 日

Publication

Incorporating Target Shedding into a Minimal PBPK-TMDD Model for Monoclonal Antibodies

Shedding of a pharmacological target from cells, giving rise to a soluble target that can also bind therapeutic proteins, is…

Certara2014 年 1 月 1 日

Publication

Anatomical, Physiological and Metabolic Changes with Gestational Age During Normal Pregnancy: A Database for Parameters Required in Physiologically-based Pharmacokinetic Modeling

Pregnancy is associated with considerable changes in the physiological, anatomical and biochemical attributes in women.…

Certara2013 年 12 月 13 日

Publication

Bottom-up Modeling and Simulation of Tacrolimus Clearance: Prospective Investigation of Blood Cell Distribution, Sex and CYP3A5 Expression as Covariates and Assessment of Study Power

The objectives were to investigate the ability of population-based in vitro-in vivo extrapolation (IVIVE) to…

Certara2013 年 12 月 1 日

Publication

An Evaluation of the Pharmacokinetics of Treprostinil Diethanolamine in Subjects with Hepatic Impairment

Treprostinil diolamine (oral treprostinil) is a prostacyclin analogue under evaluation for the treatment for pulmonary…

Certara2013 年 12 月 1 日

Publication

Modeling of Pharmacokinetic Systems Using Stochastic Deconvolution

In environments where complete mechanistic knowledge of the system dynamics is not available, a synergy…

Certara2013 年 12 月 1 日

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模型引导的药物开发

Precision Criteria to Derive Sample Size When Designing Pediatric Pharmacokinetics Studies: Which Measure of Variability Should be Used?

Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers

A Model-based Meta-analysis to Compare Efficacy and Tolerability of Tramadol and Tapentadol for the Treatment of Chronic Non-malignant Pain

A Systems Pharmacology Perspective on the Clinical Development of Fatty Acid Amide Hydrolase Inhibitors for Pain

The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?

Incorporating Target Shedding into a Minimal PBPK-TMDD Model for Monoclonal Antibodies

Anatomical, Physiological and Metabolic Changes with Gestational Age During Normal Pregnancy: A Database for Parameters Required in Physiologically-based Pharmacokinetic Modeling

Bottom-up Modeling and Simulation of Tacrolimus Clearance: Prospective Investigation of Blood Cell Distribution, Sex and CYP3A5 Expression as Covariates and Assessment of Study Power

An Evaluation of the Pharmacokinetics of Treprostinil Diethanolamine in Subjects with Hepatic Impairment

Modeling of Pharmacokinetic Systems Using Stochastic Deconvolution

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